N/A
N=312
A Study of Bimatoprost 0.01% in the Clinical Setting
Glaucoma, Primary Open Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01814761 ↗Enrolled (actual)
312
Serious AEs
1.0%
Results posted
Oct 2015
Primary outcome: Primary: Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale — 7; 36; 10; 50 Patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Bimatoprost 0.01% (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale |
7; 36; 10; 50; 12; 84 | — |
| SECONDARY Change From Baseline in Intraocular Pressure (IOP) in the Study Eye |
18.0; 17.8; -3.6; -2.6 | — |
| SECONDARY Percentage of Patients Who Discontinue Due to an Adverse Event |
14.3; 5.6 | — |
| SECONDARY Overall Percent Change From Baseline in IOP |
-19.25; -13.26 | — |
Summary
This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary open-angle glaucoma or ocular hypertension
- Determined by the treating physician to require treatment with bimatoprost 0.01%.
Exclusion Criteria
- Previous use of Lumigan® 0.01%
Data sourced from ClinicalTrials.gov (NCT01814761). 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.