Travoprost Cream for Glaucoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Glaukos Corporation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults over 18 with open-angle glaucoma or ocular hypertension in both eyes, who can legally consent and have a visual acuity of about 20/80. It's not for those allergic to travoprost or timolol, with severe asthma/COPD, certain heart conditions, cerebrovascular issues, other types of glaucoma, advanced vision loss or specific eye surgeries.

Inclusion Criteria

Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form

Best-corrected visual acuity of approximately 20/80 Snellen in each eye

I am 18 years old or older.

+2 more

Exclusion Criteria

Sensitivity or allergy to travoprost or timolol

I have had issues with blood flow to my brain.

I have a history of serious heart rhythm problems or heart failure.

+4 more

Participant Groups

The study tests the safety and effectiveness of Travoprost Ophthalmic Topical Cream at three different doses in reducing high intraocular pressure compared to Timolol maleate solution and Travoprost ophthalmic solution.

5Treatment groups

Experimental Treatment

Active Control

Group I: Travoprost Ophthalmic Topical Cream mid-doseExperimental Treatment1 Intervention

Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days

Group II: Travoprost Ophthalmic Topical Cream low-doseExperimental Treatment1 Intervention

Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days

Group III: Travoprost Ophthalmic Topical Cream high-doseExperimental Treatment1 Intervention

Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days

Group IV: Timolol maleate ophthalmic solution, 0.5%Active Control1 Intervention

Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days

Group V: Travoprost ophthalmic solution, 0.004%Active Control1 Intervention