Phase 4
Completed N=93
An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT01881126 ↗Enrolled (actual)
93
Serious AEs
1.1%
Results posted
Nov 2015
Primary outcomePrimary: Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM — 16.4; 15.1; 16.0; 15.0 Millimeters of Mercury (mmHg)
Summary
This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM |
16.4; 15.1; 16.0; 15.0; 16.5; 14.5 | — |
Eligibility Criteria
Inclusion Criteria
- Ocular hypertension or glaucoma that requires treatment with medication
- Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes
Exclusion Criteria
- History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
- History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
- Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
Data sourced from ClinicalTrials.gov (NCT01881126). 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.