Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00538304 | A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension | PHASE2 | COMPLETED | 222 | — | — | Nov 1, 2007 | May 1, 2008 | Apr 23, 2019 | 1 | United States |
Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | bimatoprost eye drops |
| 2 | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| bimatoprost eye drops | DRUG | 1 drop in each eye daily for 1 month |
| placebo | DRUG | 1 drop in each eye daily for 1 month |
Inclusion Criteria: * Chronic glaucoma or ocular hypertension * IOP controlled on Xalatan Exclusion Criteria: * Uncontrolled medical conditions * Known hypersensitivity to study medications