Article

Glaucoma Clinical Trials

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

CLINICALTRIALS.GOV IDENTIFIER: NCT03519386

SPONSOR: Glaukos Corporation

PURPOSE: Phase III study to compare the safety and efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

DESIGN: Randomized, parallel assignment, double masking

NUMBER OF PATIENTS: 1,000

INFORMATION: kstephens@glaukos.com

STUDY: A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert

CLINICALTRIALS.GOV IDENTIFIER: NCT04061044

SPONSOR: Ocular Therapeutix, Inc.

PURPOSE: To evaluate the long-term safety of repeat-dose 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: Nonrandomized, single group, no masking

NUMBER OF PATIENTS: 40

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

SPONSOR: Santen Inc.

PURPOSE: This is a Phase III, 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 wash out 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

NUMBER OF PATIENTS: 430

INFORMATION: clinicaltrials@santen.com

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

SPONSOR: Santen Inc.

PURPOSE: This is a Phase III, 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 wash out 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

NUMBER OF PATIENTS: 430

INFORMATION: clinicaltrials@santen.com

STUDY: DE-117 Spectrum 5 Study

CLINICALTRIALS.GOV IDENTIFIER: NCT03697811

SPONSOR: Santen Inc.

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

DESIGN: Single group, no masking

NUMBER OF PATIENTS: 150

INFORMATION: clinicaltrials@santen.com

STUDY: Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-angle Glaucoma or Ocular Hypertension

CLINICALTRIALS.GOV IDENTIFIER: NCT03850782

SPONSOR: 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.

DESIGN: Randomized, parallel assignment, quadruple masking

NUMBER OF PATIENTS: 300

INFORMATION: IR-CTRegistration@allergan.com

STUDY: Use of the OMNI Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma

CLINICALTRIALS.GOV IDENTIFIER: NCT03861169

SPONSOR: Sight Sciences, Inc.

PURPOSE: This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with cataract extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).

DESIGN: Single group, no masking

NUMBER OF PATIENTS: 220

INFORMATION: kdhamdhere@sightsciences.com

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

CLINICALTRIALS.GOV IDENTIFIER: NCT03323164

SPONSOR: Wills Eye

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

NUMBER OF PATIENTS: 31

STUDY: To Compare the Safety and Efficacy of Perrigo’s Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes

CLINICALTRIALS.GOV IDENTIFIER: NCT04024072

SPONSOR: Perrigo Company

PURPOSE: To compare the safety and efficacy of Perrigo’s product to an FDA-approved product in the treatment of primary open angle glaucoma or ocular hypertension in both eyes.

DESIGN: Randomized, parallel assignment, double masking

NUMBER OF PATIENTS: 450

INFORMATION: fana.said@perrigo.com

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

SPONSOR: Nicox Ophthalmics, Inc.

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

NUMBER OF PATIENTS: 550

INFORMATION: NCX470@nicox.com

STUDY: XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)

CLINICALTRIALS.GOV IDENTIFIER: NCT03654885

SPONSOR: Allergan

PURPOSE: The aim of this study is to compare the effectiveness and safety of XEN to trabeculectomy in subjects with open angle glaucoma refractory to topical medical therapy

DESIGN: Randomized, parallel assignment, no masking

NUMBER OF PATIENTS: 286

INFORMATION: IR-CTRegistration@Allergan.com

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

CLINICALTRIALS.GOV IDENTIFIER: NCT03450629

SPONSOR: Sun Pharma Advanced Research Company Limited

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

NUMBER OF PATIENTS: 666

INFORMATION: clinical.trials@sparcmail.com

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

CLINICALTRIALS.GOV IDENTIFIER: NCT03323164

SPONSOR: Wills Eye

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

NUMBER OF PATIENTS: 30

INFORMATION: MSchwartz@willseye.org

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

CLINICALTRIALS.GOV IDENTIFIER: NCT02990143

SPONSOR: The New York Eye & Ear Infirmary

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

NUMBER OF PATIENTS: 40

INFORMATION: 646-943-7925; eyeresearch@nyee.edu

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

CLINICALTRIALS.GOV IDENTIFIER: NCT02862938

SPONSOR: Stanford University

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

NUMBER OF PATIENTS: 60

INFORMATION: mnunez1@stanford.edu

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

CLINICALTRIALS.GOV IDENTIFIER: NCT02984813

SPONSOR: The New York Eye & Ear Infirmary

PURPOSE: This study is a multiarmed 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.

DESIGN: Randomized, parallel assignment, quadruple masking

NUMBER OF PATIENTS: 21

STUDY: Stop Retinal Ganglion Cell Dysfunction Study (STOP-RGCD)

CLINICALTRIALS.GOV IDENTIFIER: NCT02390284

SPONSOR: University of Miami

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.

DESIGN: Randomized, parallel assignment, no masking

NUMBER OF PATIENTS: 500

INFORMATION: mcolon@med.miami.edu

STUDY: Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

CLINICALTRIALS.GOV IDENTIFIER: NCT02754596

SPONSOR: Glaukos Corporation

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

NUMBER OF PATIENTS: 300

STUDY: Effectiveness and Safety of Cosopt Loaded Contact Lenses

CLINICALTRIALS.GOV IDENTIFIER: NCT02852057

SPONSOR: University of Florida

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 assignment, no masking

NUMBER OF PATIENTS: 50

INFORMATION: thists@shands.ufl.edu

STUDY: Ahmed Glaucoma Valve Surgery With Mitomycin-C (AMCT)

CLINICALTRIALS.GOV IDENTIFIER: NCT02805257

SPONSOR: University of California, San Francisco

PURPOSE: This study will determine the effectiveness of Mitomycin-C use in 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 assignment, double masking

NUMBER OF PATIENTS: 100

INFORMATION: ying.han@ucsf.edu

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

SPONSOR: Santen Inc.

PURPOSE: This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eye drops. 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.

DESIGN: Randomized, parallel assignment, single masking

NUMBER OF PATIENTS: 220

INFORMATION: clinicaltrials@santeninc.com

STUDY: InnFocus MicroShunt Versus Trabeculectomy Study (IMS)

CLINICALTRIALS.GOV IDENTIFIER: NCT01881425

SPONSOR: InnFocus Inc.

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

NUMBER OF PATIENTS: 857

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

CLINICALTRIALS.GOV IDENTIFIER: NCT02636946

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.

DESIGN: Randomized, parallel assignment, quadruple masking

NUMBER OF PATIENTS: 160

INFORMATION: IR-CTRegistration@allergan.com

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

CLINICALTRIALS.GOV IDENTIFIER: NCT02507687

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.

DESIGN: Randomized, parallel assignment, quadruple masking

NUMBER OF PATIENTS: 160

INFORMATION: IR-CTRegistration@allergan.com

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

CLINICALTRIALS.GOV IDENTIFIER: NCT02250651

SPONSOR: Allergan

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

NUMBER OF PATIENTS: 600

INFORMATION: IR-CTRegistration@allergan.com

STUDY: Multicenter Post-Approval Study of the Glaukos iStent Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

CLINICALTRIALS.GOV IDENTIFIER: NCT01841450

SPONSOR: Glaukos Corporation

PURPOSE: The purpose of this study is to assess the long-term safety of the Glaukos iStent Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

DESIGN: Randomized, parallel assignment, no masking

NUMBER OF PATIENTS: 360

INFORMATION: sthode@glaukos.com

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

SPONSOR: Glaukos Corporation

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

NUMBER OF PATIENTS: 1,200

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

CLINICALTRIALS.GOV IDENTIFIER: NCT01461278

SPONSOR: Glaukos Corporation

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

NUMBER OF PATIENTS: 1,200