Phase 4
N=800
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01594970 ↗Enrolled (actual)
800
Serious AEs
0.3%
Results posted
Jan 2014
Primary outcome: Primary: Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale — 40; 49; 20; 71 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bimatoprost 0.01% (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale |
40; 49; 20; 71; 54; 70 | — |
| SECONDARY Change From Baseline in Intraocular Pressure (IOP) |
18.6; 17.0; 19.3; -4.7; -2.6; -3.2 | — |
| SECONDARY Overall Percent Change From Baseline in IOP |
-22.09; -12.90; -14.37; -20.22; -12.81; -14.25 | — |
Summary
This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).
Eligibility Criteria
Inclusion Criteria
- Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01594970). 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.