Article

Glaucoma Clinical Trials

STUDY: Evaluation of Safety and Efficacy of Brimonidine Tartrate Ophthalmic Suspension

CLINICALTRIALS.GOV IDENTIFIER: NCT03450629

PURPOSE: The study will be conducted to evaluate the efficacy and safety of topical administration of brimonidine tartrate ophthalmic suspension compared with brimonidine tartrate ophthalmic solution.

DESIGN: Randomized, parallel assignment, single masking

PARTICIPANTS: 666

STUDY: A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study

CLINICALTRIALS.GOV IDENTIFIER: NCT03691649

PURPOSE: This is a phase 3, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at visit 1 (screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for visit 2 (baseline, day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months.

DESIGN: Randomized, parallel assignment, quadruple masking

PARTICIPANTS: 430

STUDY: A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

CLINICALTRIALS.GOV IDENTIFIER: NCT03691662

PURPOSE: This is a phase 3, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at visit 1 (screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for visit 2 (baseline, day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months

DESIGN: Randomized, parallel assignment, quadruple masking

PARTICIPANTS: 430

STUDY: DE-117 Spectrum 5 Study

CLINICALTRIALS.GOV IDENTIFIER: NCT03697811

PURPOSE: Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost/non-responder subjects diagnosed with POAG or OHT.

DESIGN: Single group, no masking

PARTICIPANTS: 150

STUDY: Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

CLINICALTRIALS.GOV IDENTIFIER: NCT03519386

PURPOSE: Phase 3 study to compare the safety and efficacy of intraocular implants containing travoprost at 2 different elution rates vs timolol maleate ophthalmic solution, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma or ocular hypertension.

DESIGN: Randomized, parallel assignment, double masking

PARTICIPANTS: 1,000

STUDY: Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

CLINICALTRIALS.GOV IDENTIFIER: NCT01722604

PURPOSE: The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with Azopt.

DESIGN: Randomized, parallel assignment, double masking

PARTICIPANTS: 624

STUDY: Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

CLINICALTRIALS.GOV IDENTIFIER: NCT03657797

PURPOSE: The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

DESIGN: Randomized, parallel assignment, quadruple masking

PARTICIPANTS: 550

STUDY: The Effectiveness of Ologen Collagen Matrix in Preventing Intraocular Pressure (IOP) Spikes After Ahmed Glaucoma Valve Surgery (AGV-FP7)

CLINICALTRIALS.GOV IDENTIFIER: NCT02990143

PURPOSE: The purpose of this study is to investigate whether placing Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.

DESIGN: Randomized, parallel assignment, single masking

PARTICIPANTS: 40

STUDY: Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration

CLINICALTRIALS.GOV IDENTIFIER: NCT02862938

PURPOSE: This is a randomized, sham controlled, masked clinical trial of 60 study participants with glaucoma. Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive the NT-501 encapsulated cell therapy (ECT) implant or a sham surgery (control arm), and no explant will be required.

DESIGN: Randomized, parallel assignment, single masking

PARTICIPANTS: 60

STUDY: Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study

CLINICALTRIALS.GOV IDENTIFIER: NCT03323164

PURPOSE: This study evaluates the possible acute changes in peripapillary blood flow after instillation of antiglaucoma medications in patients with primary open angle glaucoma (POAG), normal tension glaucoma (NTG), or ocular hypertension (OHTN) using Optical Coherence Tomography (OCT) angiography.

DESIGN: Randomized, parallel assignment, single masking

PARTICIPANTS: 31

STUDY: Safety and Efficacy of Anti-Oxidants and Anti-inflammatory Agents in Glaucoma and Diabetic Retinopathy

CLINICALTRIALS.GOV IDENTIFIER: NCT02984813

PURPOSE: This study is a multi-armed protocol designed to evaluate the safety and efficacy of two different combinations of nutritional supplements (study drug) (Glauco-Health and Glauco-Select) chosen for their potential to protect retinal ganglion cells against oxidative stress, low-grade inflammation, and mitochondrial dysfunction in patients with open-angle glaucoma and diabetic retinopathy. Oxidative stress and retinal cellular dysfunction will be measured using a Retinal Metabolic Analyzer (RMA) in this randomized, single center, double masked study. Patients with glaucoma will be divided into three treatment arms randomized to receive either Glauco-Health, Glauco-Select, or placebo.

DESIGN: Randomized, parallel assignment, quadruple masking

PARTICIPANTS: 21

STUDY: Stop Retinal Ganglion Cell Dysfunction Study

CLINICALTRIALS.GOV IDENTIFIER: NCT02390284

PURPOSE: This study will longitudinally monitor a population of glaucoma suspects (with positive factors for the disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG will be left untreated. All patients will be monitored with PERG, optical coherence tomography (OCT) and other ancillary tests every 6 months over 4 years.

DESIGN: Randomized, parallel assignment, no masking

PARTICIPANTS: 500

STUDY: Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

CLINICALTRIALS.GOV IDENTIFIER: NCT02754596

PURPOSE: This is a randomized trial comparing two elution doses of the travoprost intraocular implant to timolol ophthalmic solution.

DESIGN: Randomized, parallel assignment, double masking

PARTICIPANTS: 300

STUDY: Effectiveness and Safety of Cosopt Loaded Contact Lenses

CLINICALTRIALS.GOV IDENTIFIER: NCT02852057

PURPOSE: This study focuses on glaucoma therapy by drug eluting contact lenses. The contact lens will be loaded with timolol maleate and dorzolamide hydrochloride, both of which are commonly used ophthalmic drugs. Additionally, the lenses will contain vitamin E ((+) α-tocopherol) as an additive for achieving extended release of the drugs. This study is to assess the safety of the drug loaded contact lenses and the effectiveness. Effectiveness will be a drop in IOP after using the lenses.

DESIGN: Single group, no masking

PARTICIPANTS: 50

STUDY: Analysis of Aqueous and Vitreous Humor

CLINICALTRIALS.GOV IDENTIFIER: NCT02067013

PURPOSE: The overall objective of this study is to evaluate the molecular concentration of growth factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to macular degeneration, macular hole or neovascular glaucoma.

DESIGN: Nonrandomized, single group, no masking

PARTICIPANTS: 45

STUDY: Ahmed Glaucoma Valve Surgery With Mitomycin-C

CLINICALTRIALS.GOV IDENTIFIER: NCT02805257

PURPOSE: This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.

DESIGN: Randomized, single group, double masking

PARTICIPANTS: 100

STUDY: A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

CLINICALTRIALS.GOV IDENTIFIER: NCT03216902

PURPOSE: This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

DESIGN: Randomized, parallel assignment, single masking

PARTICIPANTS: 220

STUDY: InnFocus MicroShunt Versus Trabeculectomy Study

CLINICALTRIALS.GOV IDENTIFIER: NCT01881425

PURPOSE: Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

DESIGN: Randomized, parallel assignment, single masking

PARTICIPANTS: 889

STUDY: Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma

CLINICALTRIALS.GOV IDENTIFIER: NCT02371746

PURPOSE: This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.

DESIGN: Nonrandomized, parallel assignment, no masking

PARTICIPANTS: 41

STUDY: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

CLINICALTRIALS.GOV IDENTIFIER: NCT02507687

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.

DESIGN: Randomized, parallel assignment, quadruple masking

PARTICIPANTS: 210

STUDY: Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

CLINICALTRIALS.GOV IDENTIFIER: NCT02636946

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.

DESIGN: Randomized, parallel assignment, quadruple masking

PARTICIPANTS: 160

STUDY: Safety and Efficacy of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

CLINICALTRIALS.GOV IDENTIFIER: NCT02250651

PURPOSE: This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

DESIGN: Randomized, parallel assignment, triple masking

PARTICIPANTS: 527

STUDY: Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

CLINICALTRIALS.GOV IDENTIFIER: NCT02247804

PURPOSE: This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

DESIGN: Randomized, parallel assignment, triple masking

PARTICIPANTS: 594

STUDY: OTX-16-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-TP in Subjects With Open-Angle Glaucoma and Ocular Hypertension

CLINICALTRIALS.GOV IDENTIFIER: NCT02914509

PURPOSE: The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.

DESIGN: Randomized, parallel assignment, double masking

PARTICIPANTS: 550

STUDY: Multicenter Study Using Glaukos Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

CLINICALTRIALS.GOV IDENTIFIER: NCT01461291

PURPOSE: Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

DESIGN: Randomized, parallel assignment, single masking

PARTICIPANTS: 1,200

STUDY: Multicenter Investigation of the Glaukos Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

CLINICALTRIALS.GOV IDENTIFIER: NCT01461278

PURPOSE: Evaluate the safety and efficacy of the Glaukos Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

DESIGN: Randomized, parallel assignment, single masking

PARTICIPANTS: 1,200