Phase 3
Completed N=561
Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT01177098 ↗Enrolled (actual)
561
Serious AEs
1.4%
Results posted
Mar 2013
Primary outcomePrimary: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 — 25.41; 25.38; 24.79; 24.72 mm Hg
Summary
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 |
25.41; 25.38; 24.79; 24.72; 23.88; 23.82 | — |
| PRIMARY Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 |
16.23; 16.49; 16.05; 16.23; 15.49; 15.83 | — |
| PRIMARY Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 |
16.28; 16.31; 15.90; 16.17; 15.71; 15.82 | — |
| PRIMARY Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 |
16.29; 16.56; 16.18; 16.37; 15.85; 16.09 | — |
| SECONDARY Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 |
25.34; 25.30; 24.71; 24.61; 23.81; 23.80 | — |
| SECONDARY Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 |
24.94; 24.86; 24.29; 24.23; 23.42; 23.36 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has ocular hypertension or glaucoma in both eyes
- Requires IOP-lowering therapy in each eye
Exclusion Criteria
- Active or recurrent eye disease that would interfere with interpretation of study data in either eye
- History of any eye surgery or laser in either eye within 6 months
- Required chronic use of other eye medications during the study
- Anticipated wearing of contact lenses during the study.
- Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Data sourced from ClinicalTrials.gov (NCT01177098). 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.