Phase 2
Completed N=222
A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT00538304 ↗Enrolled (actual)
222
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 — 0.32; 0.30; 0.18; 0.02 Number on a scale (score)
Summary
A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 |
0.32; 0.30; 0.18; 0.02 | — |
| SECONDARY Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1 |
8.16; 1.41 | — |
| SECONDARY Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 |
18.2; 18.0; -1.0; 3.6 | — |
| SECONDARY Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1 |
85.7; 39.5 | — |
| SECONDARY Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1 |
88.5; 52.9 | — |
| SECONDARY Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1 |
95.1; 94.1 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic glaucoma or ocular hypertension
- IOP controlled on Xalatan
Exclusion Criteria
- Uncontrolled medical conditions
- Known hypersensitivity to study medications
Data sourced from ClinicalTrials.gov (NCT00538304). 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.