Phase 2
N=109
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
Open-Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01157364 ↗Enrolled (actual)
109
Serious AEs
17.4%
Results posted
Mar 2020
Primary outcome: Primary: Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye — 26.57; 25.14; 24.48; 25.14 Millimeters of Mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bimatoprost 20 µg generation 2 (Drug); bimatoprost 15 µg generation 2 (Drug); bimatoprost 10 µg generation 2 (Drug); bimatoprost 6 µg generation 2 (Drug); bimatoprost 15 µg generation 1 (Drug); bimatoprost 10 µg generation 1 (Drug); bimatoprost 0.03% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye |
26.57; 25.14; 24.48; 25.14; 23.73; 24.22 | — |
| SECONDARY Time-Matched Intraocular Pressure (IOP) in the Study Eye |
26.57; 25.14; 24.48; 25.14; 23.73; 24.22 | — |
| SECONDARY Mean Diurnal IOP in the Study Eye |
23.38; 23.74; 23.02; 23.54; 20.84; 22.09 | — |
| SECONDARY Time to Rescue Treatment or Re-Treatment in the Study Eye |
328; 265; 273; 391.5; 411; 237 | — |
Summary
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of open angle glaucoma or ocular hypertension
Exclusion Criteria
- Uncontrolled medical conditions
- Anticipated wearing of contact lenses during the study
Data sourced from ClinicalTrials.gov (NCT01157364). 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.