TITLE: Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution
SPONSOR: Bausch and Lomb Incorporated
BRIEF SUMMARY: To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects.
TITLE: Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis
SPONSOR: Bausch and Lomb Incorporated
BRIEF SUMMARY: To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:
Title: A Phase 2, Randomized, Placebo-Controlled, Double-Masked Study To Access Safety And Efficacy Of Multiple Doses Of Ionis-fb-lrx, an Antisense Inhibitor Of Complement Factor b, In Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration (AMD) (Golden)
SPONSOR: IONIS
Objective: To evaluate the effect of ISIS 696844 on the rate of change of the area of GA secondary to AMD measured by fundus autofluorescence (FAF) Secondary Objectives To evaluate the effect of ISIS 696844 on plasma FB levels and serum AH50 activity in AMD patients To assess the effect of ISIS 696844 to slow reduction of low luminance visual acuity (LLVA).
TITLE: Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
SPONSOR: EyePoint Pharmaceuticals, Inc
BRIEF SUMMARY: This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.
Title: A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Sponsor: AbbVie ( formerly Allergan)
Purpose: This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.
TITLE: OCS-01: A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
SPONSOR: Oculis
BRIEF SUMMARY: The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.
TITLE: A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema (Rhone-X)
SPONSOR: Hoffmann-La Roche
BRIEF SUMMARY: This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.
TITLE: A Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (Oculis)
SPONSOR: OCULIS
BRIEF SUMMARY: The purpose of this study is to evaluate the efficacy and safety of OCS-01 ophthalmic suspension versus vehicle alone in subjects with DME.
Title: A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512 (COMET-4)
Sponsor: Aerie Pharmaceuticals
Brief Summary: This will be a 12-month, multicenter, vehicle-controlled, double-masked, randomized Phase 3 study conducted at approximately 10 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of a Baseline (Day 1) visit as well as visits at Day 14, Day 90, Day 180, Day 270, and Day 365 (Study Exit).
Title: Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 Nasal Spray in Subjects with Neurotrophic Keratopathy (the Olympia Study)
Sponsor: Oyster Point Pharma, Inc.
Purpose: The objective of this study is to evaluate the safety and effectiveness of OC-01 nasal spray as compared to placebo nasal spray for complete resolution of corneal staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.
TITLE: A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)
SPONSOR: Kodiac Sciences, Inc.
Objective: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)
Title: PROSPECTIVE, RANDOMIZED PHASE 3 STUDY COMPARING TWO MODELS OF A TRAVOPROST INTRAOCULAR IMPLANT TO TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP, 0.5%
Sponsor: GLAUKOS CORPORATION
Purpose: To compare the safety and initial efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, USP, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Title: Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor: Allergan
Purpose: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.
Title: A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Neovascular Age-Related Macular Degeneration (Avonelle-X)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: This study will evaluate the long-term safety and tolerability of intravitreal (IVT) faricimab in patients with neovascular age-related macular degeneration (nAMD) who have completed either of the Phase III (GR40306 or GR40844) studies. Additional assessments relating to efficacy, pharmacokinetics, immunogenicity, and biomarkers will be performed.
Title: A PHASE III, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC RETINOPATHY (PAVILION)
Sponsor: F. Hoffman-La Roche Ltd.
Purpose: To evaluate the efficacy, safety, and pharmacokinetics of Ranibizumab delivered via the Port Delivery System in patients with Diabetic Retinopathy.
Title: A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System with Ranibizumab in Patients with Diabetic Macular Edema. (GR40550 PAGODA)
Sponsor: F. Hoffman-La Roche Ltd.
Purpose: Evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab in patients with Diabetic Macular Edema (DME).
Title: PROSPECTIVE, RANDOMIZED PHASE 3 STUDY COMPARING TWO MODELS OF A TRAVOPROST INTRAOCULAR IMPLANT TO TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP, 0.5%
Sponsor: GLAUKOS CORPORATION
Purpose: To compare the safety and initial efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, USP, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Title: Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor: Allergan
Purpose: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.
Title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study To Evaluate The Efficacy And Safety Of Faricimab In Patients With Macular Edema Secondary To Branch Retinal Vein Occlusion (Balaton)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: Objective: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to branch retinal vein occlusion (BRVO) up to the primary endpoint at Week 24. Efficacy, safety, and pharmacokinetics of faricimab administered according to the personalized treatment interval (PTI) dosing regimen (i.e., from every 4 weeks [Q4W] to every 16 weeks [Q16W]) will be assessed during the study period from Weeks 24 to 72.
Title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study To Evaluate The Efficacy And Safety Of Faricimab In Patients With Macular Edema Secondary To Central Retinal Or Hemi Retinal Vein Occlusion (Comino)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) up to the primary endpoint at Week 24. Efficacy, safety, and pharmacokinetics of faricimab administered according to the personalized treatment interval (PTI) dosing regimen (i.e., from every 4 weeks [Q4W] to every 16 weeks [Q16W]) will be assessed during the study period from Weeks 24 to 72.
Title: A Longitudinal, Biomarker Study Of Anti-VEGF, to Explore the Relationship Between Aqueous Humor Composition And Multimodal Retinal Imaging In Neovascular Age-Related Macular Degeneration And Diabetic Macular Edema (Longitude)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: This is an open-label, multicenter, non-randomized, two-cohort, biomarker study in treatment-naïve study eyes of 100 nAMD participants and treatment-naïve study eyes of 100 DME participants to explore the composition of AH and features of multimodal retinal imaging before and during a six-month treatment period with aflibercept.
TITLE: (Gleam) A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)
SPONSOR: Kodiac Sciences, Inc.
Objective: This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME. The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.
TITLE: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) (Daylight)
SPONSOR: Kodiac Sciences, Inc.
Purpose: This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD). The primary endpoint will be assessed at Week 40; additional secondary endpoints for efficacy will be assessed by visit over time.