Last updated: November 30, 2023
Sponsor: Glaukos Corporation
Overall Status: Active - Recruiting
Phase
2
Condition
Glaucoma
Ocular Hypertension
Circulation Disorders
Treatment
Travoprost Ophthalmic Topical Cream mid-dose
Travoprost Ophthalmic Topical Cream high-dose
Timolol maleate ophthalmic solution, 0.5%
Clinical Study ID
NCT06152861
GLK-311-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 informedconsent 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
Exclusion Criteria:
- Sensitivity or allergy to travoprost or timolol;
- Bronchial asthma, a history of bronchial asthma, or severe chronic obstructivepulmonary disease;
- History of or current sinus bradycardia, second- or third-degree atrioventricularblock, 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
Study Design
Total Participants: 250
Treatment Group(s): 5
Primary Treatment: Travoprost Ophthalmic Topical Cream mid-dose
Phase: 2
Study Start date:
November 15, 2023
Estimated Completion Date:
August 31, 2024
Connect with a study center
Glaukos Clinical Study Site
Newport Beach, California 92663
United StatesActive - Recruiting
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