Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension
NCT06152861 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2023-12-06
Summary
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%.
Conditions
Interventions
- DRUG
-
Travoprost Ophthalmic Topical Cream low-dose
travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes
- DRUG
-
Travoprost Ophthalmic Topical Cream mid-dose
travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes
- DRUG
-
Travoprost Ophthalmic Topical Cream high-dose
travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes
- DRUG
-
Timolol maleate ophthalmic solution, 0.5%
timolol maleate ophthalmic solution, 0.5% twice daily (morning \& evening) to both eyes
- DRUG
-
Travoprost Ophthalmic Solution, 0.004%
travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes
Sponsors & Collaborators
-
Glaukos Corporation
lead INDUSTRY
Principal Investigators
-
Study Director · Glaukos Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-15
- Primary Completion
- 2024-08-31
- Completion
- 2024-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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