Travoprost Five Day Posology Study

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Travoprost

Criteria

Inclusion Criteria:

1. either sex and any race/ethnicity, ≥18 years old

2. diagnosed with open-angle glaucoma, and/or ocular hypertension

3. meets the following IOP entry criteria:

• Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1

• Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1

4. satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

1. females of childbearing potential not meeting protocol conditions

2. angle grade less than Grade 2 in either eye

3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye

4. severe central visual field loss in either eye

5. any abnormality preventing reliable applanation tonometry in either eye

6. hypersensitivity to prostaglandin analogues or to any component of the study medication