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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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%.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Glaukos Clinical Study Site
RECRUITING
Newport Beach
Contact Information
Primary
Study Clinical Trial Associate
SVea@glaukos.com
949-367-9600
Backup
Study Manager
PBraswell@glaukos.com
949-367-9600
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2024-08
Participants
Target number of participants: 250
Treatments
Experimental: Travoprost Ophthalmic Topical Cream low-dose
Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days
Experimental: Travoprost Ophthalmic Topical Cream mid-dose
Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days
Experimental: Travoprost Ophthalmic Topical Cream high-dose
Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days
Active_comparator: Timolol maleate ophthalmic solution, 0.5%
Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days
Active_comparator: Travoprost ophthalmic solution, 0.004%
Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days
Sponsors
Leads: Glaukos Corporation

This content was sourced from clinicaltrials.gov

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