Phase 2
Completed N=67
Travoprost Five Day Posology Study
Open-angle Glaucoma (OAG) · Hypertension
Source: ClinicalTrials.gov NCT01114893 ↗
Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 — -9.8; -2.9; -5.0; -6.5 mm Hg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 |
-9.8; -2.9; -5.0; -6.5; -6.8 | — |
| SECONDARY IOP Change From Baseline at 8 PM on Day 5 |
-3.9; -0.9; -2.7; -5.7; -4.8 | — |
Eligibility Criteria
Inclusion Criteria
- either sex and any race/ethnicity, ≥18 years old
- diagnosed with open-angle glaucoma, and/or ocular hypertension
- 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
- satisfies all informed consent requirements; able to read, sign and date the informed consent
Exclusion Criteria
- females of childbearing potential not meeting protocol conditions
- angle grade less than Grade 2 in either eye
- cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
- severe central visual field loss in either eye
- any abnormality preventing reliable applanation tonometry in either eye
- hypersensitivity to prostaglandin analogues or to any component of the study medication
Data sourced from ClinicalTrials.gov (NCT01114893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.