Phase 3
Completed N=597
Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT01099774 ↗Enrolled (actual)
597
Serious AEs
1.2%
Results posted
Apr 2012
Primary outcomePrimary: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 — 24.90; 24.86; 23.79; 23.78 Millimeters of Mercury (mmHg)
Summary
This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) 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 Week 12 |
24.90; 24.86; 23.79; 23.78; 22.81; 22.80 | — |
| PRIMARY Average Eye IOP at Week 12 |
24.53; 24.46; 23.30; 23.26; 22.31; 22.29 | — |
| PRIMARY Average Eye IOP at Week 6 |
17.16; 17.08; 16.52; 16.45; 16.56; 16.32 | — |
| PRIMARY Average Eye IOP at Week 2 |
17.40; 17.14; 16.68; 16.43; 16.61; 16.39 | — |
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 (NCT01099774). 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.