Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension

GLK-311-01

The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.

2023-11-15

2024-08-01

2024-08-01

Recruiting

Early phase I

250

Inclusion Criteria: * Male or female, 18 years of age or older at the Screening Visit; * Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form; * Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes; * Qualifying IOP in the study eye; * Best-corrected visual acuity of approximately 20/80 Snellen in each eye Exclusion Criteria: * Sensitivity or allergy to travoprost or timolol; * Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease; * History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock; * History of cerebrovascular insufficiency; * Any form of glaucoma other than open-angle glaucoma * Advanced visual field loss or cup-to-disc ratio of 0.8 or greater * Non-qualifying prior surgeries or procedures in either eye

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}

2023-12-06