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Prostaglandin Analog

Travoprost Cream for Glaucoma

Phase 2
Recruiting
Research Sponsored by Glaukos Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes
Be older than 18 years old
Must not have
History of cerebrovascular insufficiency
History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29
Awards & highlights

Summary

This trial studies a new eye cream to help lower eye pressure in people with glaucoma or high eye pressure.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include eye redness, discomfort or irritation; changes in eyelash growth; darkening of the iris; dry mouth; fatigue; headache; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with open-angle glaucoma or high eye pressure in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had issues with blood flow to my brain.
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I have a history of serious heart rhythm problems or heart failure.
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I have asthma or severe COPD.
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My vision loss is severe or my eye exam shows significant changes.
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I have not had any disqualifying surgeries or procedures in either eye.
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I have a type of glaucoma that is not open-angle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change from baseline in mean diurnal IOP in the study eye

Trial Design

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
Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days

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Who is running the clinical trial?

Glaukos CorporationLead Sponsor
66 Previous Clinical Trials
9,035 Total Patients Enrolled
Study DirectorStudy DirectorGlaukos Corporation
1,252 Previous Clinical Trials
504,129 Total Patients Enrolled
~136 spots leftby Sep 2025
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