Topical cream for treating open-angle glaucoma and ocular hypertension

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

This study is testing a new cream for treating open-angle glaucoma and high eye pressure to see if it works better than current treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Glaukos Corporation (industry)
• Locations: 1 site (Newport Beach, California)
• Trial ID: NCT06152861 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Travoprost Ophthalmic Topical Cream in reducing intraocular pressure in patients diagnosed with open-angle glaucoma or ocular hypertension. Participants will receive varying doses of the cream, which will be compared to standard treatments including timolol maleate ophthalmic solution and travoprost ophthalmic solution. The study aims to determine how well the topical cream works in managing high intraocular pressure, a critical factor in glaucoma treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of open-angle glaucoma or ocular hypertension and qualifying intraocular pressure levels.

Not a fit: Patients with other forms of glaucoma, significant visual field loss, or those with certain medical conditions such as severe asthma or cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients struggling with high intraocular pressure due to glaucoma or ocular hypertension.

How similar studies have performed: Other studies have shown promise in using topical treatments for glaucoma, but this specific approach with Travoprost Ophthalmic Topical Cream is relatively novel.

Eligibility criteria

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

Where this trial is running

Newport Beach, California

• Glaukos Clinical Study Site — Newport Beach, California, United States (RECRUITING)

Study contacts

• Study coordinator: Study Clinical Trial Associate

Conditions: Open Angle Glaucoma, Ocular Hypertension