A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) with Placebo for the Treatment of Geographic Atrophy Associated with Dry Age-Related Macular DegenerationMar 2013
To determine if ACU-4429 reduces the rate of progression of geographic atrophy (GA) compared to placebo in subjects with dry age-related macular degeneration (AMD).
Vision Restoration Training in Glaucoma (VRT-G)Feb 2013
Importance: Visual field loss after retinal damage in glaucoma is considered irreversible and methods are needed to achieve vision restoration. Behavioral vision restoration training (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise such a method. Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT by daily one hour training for 3 months improves detection performance in perimetry compared to a vision discrimination task in the intact visual field sector.
Study on Ocular Blood Flow and the Orbital Cerebrospinal Fluid Pressure in GlaucomaFeb 2013
Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in flow velocities in the retrobulbar arteries in what appears to be related to the degree of the glaucomatous disease. The anatomic pathway of the several arteries into the eye is intricately complicate, with at least one of them (the central retina artery) penetrating the optic nerve before entering the eye and supplying the innermost structures of the globe. As the optic nerve is surrounded by a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of the central nervous system, this central retinal artery has also to cross this CSF containing compartment. Because of the intrinsic pressure this CSF - corresponding to the intracranial pressure at the orbital level - the possibility exists that this pressure around the optic disc could affect the blood flow of the arteries that go through it. The investigators will try to detect if a correlation exists between the optic nerve sheath diameter and the blood flow in the retrobulbar vessels of glaucoma patients.
Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma PatientsFeb 2013
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients
Correlation of Orbital Cerebrospinal Fluid Pressure and Retinal Venous Outflow in Primary Open-angle GlaucomaFeb 2013
A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can potentially be found in up to 98% of healthy individuals. In fact, the lack of this spontaneous retinal venous pulse has been consistently implicated as an indicator of a more advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the mechanisms behind these change in the retinal venous system are not clear. Some evidence suggests that extraocular features such as intracranial pressure (ICP) may play a role in regulating the intraocular venous outflow. The reasons for this hypothetical downstream resistance to venous outflow are not fully understood, with advances in this field being limited by our technological-imposed difficulties in assessing the structures behind the globe. However, it has been established that the volume of cerebrospinal fluid surrounding the optic nerve correlates with the ICP at the orbital level. Recent studies have suggested that non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range (normal tension glaucoma - NTG). The investigators will therefore conduct a test to determine if this cerebrospinal volume surrounding the optic nerve correlates with the frequency of observation of an otherwise signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein) Additionally, the investigators will assess if this correlation is different between healthy individuals, hypertensive primary-open angle glaucoma or NTG patients.
Study on the Oxygen Saturation in Pulsating and Non-pulsating Central Retinal VeinsFeb 2013
Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Recent findings have confirmed that there is a direct correlation between the levels of venous oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in retinal cell metabolism. However, glaucoma patients have been suggested to have a different pattern in retinal venous circulation. For instance, the observation of a visible pulsating central retinal vein is a phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in less than 50% of glaucoma patients. While the nature of these venous changes are not year clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous pressure due to some obstruction from both ocular or extraocular structures. This undetermined increase in venous pulse pressure could then significantly decrease perfusion pressures and therefore further decrease oxygen supply to the retinal tissues. The investigators will therefore try to determine if there is a significant difference between the oxygen saturation of the retinal vessels in both glaucoma patients with and without a visible pulsating central vein
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)Feb 2013
This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment strategy for glaucoma patients. It is done with a laser device that can also be used for many other ophthalmic applications, thus reducing the economic burden of treatment.
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination TherapyJan 2013
The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.
Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study (INCISIONS)Jan 2013
One aim of the study is to assess the influence of the intra-operative wound architecture using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to deformation of the wound and the surgically induced astigmatism in MICS and small incision cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged incision with a pre-cut should be assessed along the same line
Intravitreal Tissue Plasminogen Activator (tPA), Perfluoropropane (C3F8), and Ranibizumab for Neovascular Age-Related Macular Degeneration and Submacular Haemorrhage (TAPAS): A Randomized, Double-Masked, Controlled, Factorial, Feasibility StudyJan 2013
To determine if intravitreal tissue plasminogen activator (tPA), gas (C3F8) and ranibizumab promote the resolution of submacular haemorrhage (SMH) due to neovascular (wet) age-related macular degeneration, and improve the visual outcome. The primary outcome measure will be the change in mean ETDRS visual acuity at 3 months following treatment.
fMRI analysis of the visual cortex in neovascular age-related macular degenerationJan 2013
To evaluate the activation pattern of the primary visual cortex in nAMD patients before and after ranibizumab therapy and to compare it with healthy controls.
A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract SurgeryJan 2013
This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized, prospective, single-center, multi-surgeon, investigator masked study to investigate whether the femtolaser cataract surgery causes any significant differences in the resulting Intra Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of mass.
IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser TrabeculoplastyJan 2013
Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients. The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.
Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAGJan 2013
Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has not been studied in a prospective manner and remains to be elucidated. The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients. (Pascal)Jan 2013
The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.
PRevention of Macular EDema After Cataract Surgery (PREMED)Jan 2013
Cystoid macular edema (CME) is a swelling of the central and most important part of the retina. It is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. However, no randomised controlled clinical trial (RCT) has compared all the currently existing preventive interventions and no study has been conducted to investigate whether combining different preventive strategies has an additional effect. Therefore, the investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM). This is a non-inferiority trial and for that reason our null hypothesis states that all treatment options are equally effective. The outcomes of this RCT will be of benefit to all cataract surgeons.
Intervention Trial in Early Age-related Macular Degeneration (I-TEAM)Sep 2012
The purpose of the I-TEAM project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.
The Most Effective Treatment Strategy for Diabetic Macular Edema.Sep 2012
To evaluate whether laser photocoagulation prolongs treatment effect of anti-VEGF for DME.
A phase 2 multi-center, randomized, double-masked, placebo controlled, multi-dose study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of RN6G (PF 04382923) in subjects with geographic atrophy secondary to age-related macular degenerationAug 2012
To determine the efficacy of RN6G in subjects with geographic atrophy in the study eye.
A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of an Investigational Eye Drop Formulation with OPTIVE™ Unit-Dose for 3 Months in Subjects with Dry Eye DiseaseJul 2012
To evaluate the safety and efficacy of Eye Drops New Platform Unit-Dose (EDNP UD) in subjects with signs and symptoms of dry eye disease
Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)Jul 2012
In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.
Evaluation of the effects of the addition of atropine during propofol/remifentanil induction of anesthesia on hemodynamics, microvascular blood flow and tissue oxygenenation in patients undergoing ophthalmic surgeryJun 2012
Evaluation of the effects of the addition of atropine during propofol/remifentanil induction of anesthesia on hemodynamics, microvascular blood flow and tissue oxygenenation in patients undergoing ophthalmic surgery
A Prospective, Randomized, Doubled-masked, Single Center, Clinical Comparison of Autologous Serum, Heterologous Serum and Umbilical Cord Serum Eye Drops in the Management of Dry Eye SyndromeMay 2012
To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord therapy in patients with severe dry eye syndrome. To accomplish clinical comparison of the effects between the three therapies.
Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).May 2012
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular age-related macular degeneration (AMD)
The effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathyApr 2012
To assess the change in tear film thickness in eyes with thyroid-associated ophthalmopathy treated with intravenous glucocorticoids
Proton Beam Radiation Therapy for Intraocular and Periocular RetinoblastomaApr 2012
The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention.
Molecular Analysis of RetinoblastomaApr 2012
The objective of this protocol is to begin to identify the mutations and gene expression changes that occur in retinoblastoma cells following RB1 gene inactivation in order to more effectively target chemotherapy for treating bilateral retinoblastoma.
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular DegenerationApr 2012
The purpose of this study is to determine the efficacy, safety and tolerability of multiple doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration.
Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular StageMar 2012
For selected cases with advanced Retinoblastoma (RTB) intraocular involvement(stage V of the Reese-Ellsworth classification) in which enucleation would usually be the standard therapeutic approach, in this project the investigators propose an alternative conservative treatment using intra-arterial chemotherapy with melphalan, via direct administration by catheterization of the ophthalmic artery.
Comparison of the effects of Bimatoprost 0.01% and Timolol 0.5% on circadian intraocular pressureMar 2012
To investigate the 24-hour IOP lowering efficacy and safety of Bimatoprost 0.01% administered once at night compared to Timolol 0.5% administered twice daily
Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases (iPhot)Mar 2012
Using an adaptive optics imaging device, retinal structures are observed in healthy and diseased subjects.
A phase III , multicentre, randomised, investigator-masked, cross-over, comparative efficacy study of a generic Brinzolamide 10 mg/ml ophthalmic suspension (Azad Pharma AG) and Brinzolamide 10 mg/ml ophthalmic suspendion (Azopt®, Alcon) in open-angle glaucoma and ocular hypertension patients.Jan 2012
The primary objective of this study is to evaluate the efficacy of Brinzolamide 10 mg/ml ophthalmic suspension (Azad Pharma AG) in lowering intraocular pressure (IOP) when compared to Azopt® ophthalmic suspension ( Brinzolamide Alcon,).
Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)Jan 2012
To assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior bimatoprost 0.03% /timolol 0.5% pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.
Intra-arterial Chemotherapy for Children With RetinoblastomaDec 2011
Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye. This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.
Quality of Life in Children Cured of RetinoblastomaDec 2011
The aim of the study is to assess the quality of life of children who have been cured of retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses standardized quality of life assessment tools.
Long-term Follow-up of Patients Who Participated in the Multicenter Uveitis Steroid Treatment Trial (MUST Trial Follow-up Study).Nov 2011
The main purpose of this trial is to compare how two different uveitis treatments control uveitis over a longer period of time.
A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients With GlaucomaOct 2011
To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of once-daily bimatoprost 0.03% preservative-free (PF) ophthalmic solution compared with twice-daily timolol (0.5% or 0.25%, based on age group) ophthalmic solution for 12 weeks in paediatric patients with glaucoma.
Multi-Center Study Assessing Efficacy and Tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative (0.004% travoprost) in Patients Previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution Monotherapy.Sep 2011
Change in IOP (on TRAVATAN® Solution without BAK, containing Polyquad® Preservative) at the 12 week visit from prior latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (baseline).
Safety and efficacy study with ESBA1008 versus Lucentis for the treatment of exudative age-related macular degenerationSep 2011
To assess the safety and tolerability of treatment following a single intravitreal administration of ESBA1008 compared to Lucentis in patients with exudative AMD
Single and Repeat Dose Study of the Safety and Efficacy of AGN-150998 in Patients with Exudative Age-related Macular DegenerationAug 2011
(1) Identify the highest or maximum tolerated dose of AGN-150998 (stage 1) (2) Assess the safety and duration of treatment effect on retinal edema and best corrected visual acuity (stage 1 + stage 2) (3) To characterize the systemic pharmacokinetic profile of AGN-150998. (stage 1+2)
Management of recurrent or persistent choroidal neovascularization secondary to age-related macular degeneration A prospective, randomized, clinical studyJul 2011
To assess the treatment effect of reduced fluence photodynamic therapy (PDT) and ranibizumab versus intravitreal dexamethasone and ranibizumab versus ranibizumab monotherapy in patients with persistent or recurrent CNV due to AMD.
Efficacy and Safety of Brinzolamide 10 mg/ml / Brimonidine 2 mg/ml Eye Drops, Suspension Compared to Brinzolamide 10 mg/ml Eye Drops, Suspension plus Brimonidine 2 mg/ml Eye Drops, Solution in Patients with Open-Angle Glaucoma or Ocular HypertensionApr 2011
The primary objective of this study is to demonstrate that the fixed combination (BID) brinzolamide 10 mg/mL / brimonidine 2 mg/mL eyes drops, suspension is non-inferior to the unfixed combination (BID) brinzolamide 10 mg/mL eye drops, suspension plus brimonidine 2 mg/mL eyes drops, solution with respect to IOP-lowering efficacy. The primary efficacy endpoint is an assessment of mean diurnal IOP change from baseline at Month 3 (patient IOP change from baseline averaged over the 9 AM, and +2 Hrs time points).
The effect of bevacizumab treatment on reading ability in age related macular degenerationDec 2010
To document the effect of intravitreal bevacizumab treatment on reading ability and foveal and parafoveal vision in age related macular degeneration (wet form)
Randomized, Double-Masked, Active Controlled, Crossover Phase III Equivalence Study of Travoprost Eye Drops Solution in Subjects with Open Angle Glaucoma or Ocular HypertensionDec 2010
To assess the equivalence of the topically administered Travoprost 0.004 % eye drops, solution (test formulation) compared to Travatan® 40 µg/ml Augentropfen (reference formulation) in lowering intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
Clonidine as an adjuvant to prolong local anaesthesia in ophthalmic surgery with cryocoagulation. A randomized, controlled, patient-masked trial.Nov 2010
To determine the beneficial effect of a single dose of 150 µg clonidine as an adjuvant to chirocaine in retrobulbar block.
A phase IV, long-term, open-label, multicenter extension study to evaluate the safety and tolerability of ranibizumab in subjects with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)Oct 2010
This extension study will investigate the long-term safety and tolerability of multiple intravitreal injections of open-label ranibizumab administered to subjects with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) who have been previously treated in either of the two ongoing ranibizumab studies RFB002A2302 (EXCITE) or RFB002A2303 (SUSTAIN). The primary objective of the study will be to assess the incidence and severity of ocular and non ocular adverse events during the 24 month study period.
Comparison of Incidence and Severity of conjunctival hyperemia associated with use of topical Bimatoprost 0.01% and latanoprost 0.005% in Glaucoma or Ocular Hypertensive patientsSep 2010
The main objective of this study is to compare conjuntival Hyperemia caused by two different treatments (lumigan 0.01% vs xalatan)
A phase 2, randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous injections of E10030 (anti-PDGF pegylated aptamer) given in combination with lucentis® in subjects with neovascular age-related macular degenerationMar 2010
The objectives of this study are to evaluate the safety and efficacy profile of E10030 intravitreous injection when administered in combination with Lucentis® 0.5 mg/eye against a control of Lucentis® 0.5 mg/eye alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD)
An open-label, multi-center, continued access trial of investigational drug ASA404 for patients in previous ASA404 clinical trialsFeb 2010
To continue to collect and review safety data in patients who have completed at least 2 cycles of ASA404 in conjunction with a taxane-based chemotherapy in one of the following Novartis sponsored ASA404 studies until ASA404 is commercially available or the project has been discontinued:CASA404A2105, CASA404A2109, CASA404A2111, CASA404A2112, CASA404A2113, CASA404A1102
A Multicenter, Randomized, Double-Masked, Parallel-Group Study Evaluating the Efficacy and Safety of Cyclosporine Ophthalmic Solution 0.010% Compared with its Vehicle Administered QID for 3 months Followed by a 9 Month Open-Label Phase in Patients with Atopic Keratoconjunctivitis.Aug 2009
To evaluate the efficacy and safety of COS 0.010% compared to its vehicle in the treatment of Atopic Keratoconjunctivitis (AKC).
A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects with Exudative Age-Related Macular Degeneration (AMD)May 2009
To evaluate the safety and preliminary efficacy of intravitreal ocriplasmin in patients with exudative AMD with focal vitreomacular adhesion
The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin MonotherapyApr 2009
To assess the safety and efficacy of adding to BTFC to prostaglandin monotherapy.
The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)Apr 2009
To evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus vehicle administered as a topical ocular drop for the treatment of geographic atrophy secondary to AMD.
New conservative therapies in Retinoblastoma: direct intraarterial (ophtalmic artery) chemotherapy with Melphalan for intraocular retinoblastomaSep 2008
Definition of a microtheterization angiographic technique to repeatedly selective cannulation of the ofthalmic artery in RTB patients. Selective intraocular infusion of an active and effective chemotherapeutic agent in advanced RTB.
A Multi-Center, Double-Masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN® in Patients with Open-Angle Glaucoma or Ocular HypertensionAug 2008
To compare the efficacy and safety of Travoprost APS to TRAVATAN both dosed once-daily in the evening, in patients with open-angle glaucoma or ocular hypertension
Long-term (3 years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapeutic doses (2.5/5/7.5 mg b.i.d.) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris. An international, double-blind placebo controlled study.May 2008
To document the absence of retinal toxicity of ivabradine versus placebo in chronic stable angina patients after treatment cessation in the subset of patients with emergent bilateral relevant ERG abnormalities observed under treatment at M36.
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye SyndromeFeb 2008
To demonstrate the superiority of NOVA22007 (CsA 0.1%) ophthalmic cationic emulsion, administered once daily versus Vehicle in patients with moderate to severe dry eye syndrome after a 6-month treatment period
Phase III Study of Multimodality Therapy Comprising Induction Chemotherapy, High-Dose Consolidation Chemotherapy, Autologous Stem Cell Transplantation, and/or Radiotherapy in Children With Extraocular RetinoblastomaFeb 2008
- To estimate the proportion of children with extraocular retinoblastoma who achieve long-term event-free survival after treatment with aggressive multimodality therapy compared to historical controls. - To estimate the response rate to the induction phase of the regimen. - To evaluate the toxicities associated with this regimen.
Phase IV randomised double masked clinical trial: Assessing morning versus evening dosing of a fixed dose combination of Travoprost 0.004% / Timolol Maleate 0.5% in patients with primary open angle glaucoma or ocular hypertension.Jan 2008
To assess the IOP-lowering efficacy at 9 am, 11 am and 4 pm of a fixed combination of Travoprost 0.004% / Timolol Maleate 0.5% dosed in the morning versus the same fixed combination dosed in the evening, in patients with open-angle glaucoma or ocular hypertension, who have an IOP insufficiently controlled (IOP ≥ 19 to ≤ 28 mmHg) by prior prostaglandin analogue monotherapy.
The effect of simvastatin (Zocor) on enhancement of ocular blood flow in glaucoma patientsJul 2007
To look at the ocular bloodflow after simvastatine intake
A trial of intranasal remifentanil for painful ophthalmic procedures.May 2006
Determine whether effective pain relief is achieved
A Six-Week, multicenter, randomized, double-masked study to evaluate the efficacy and safety of dosing once-daily Travoprost/Timolol in the morning vs. twice-daily Dorzolamide/Timolol in patients with open-angle glaucoma or ocular hypertension.Jan 2006
The primary objective of this study is to compare the IOP-lowering efficacy and safety of dosing of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (once-daily morning dosing) vs. Dorzolamide 2%/Timolol 0.5% Ophthalmic Solution, dosed twice-daily, in patients with open-angle glaucoma or ocular hypertension.
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular HypertensionJan 2006
Main objective:to compare the safety and IOP-lowering efficacy of Brinzolamide 1,0%/ Timolol 0,5 % Ophthalmic Suspension to COSOPT® in patients with open-angle glaucoma or ocular hypertension.