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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00201981 | Study of Rebamipide Eye Drops to Treat Dry Eye | PHASE3 | COMPLETED | 740 | — | — | May 1, 2004 | Feb 1, 2007 | Jan 7, 2008 | 63 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | rebamipide 1% |
| 2 | ACTIVE_COMPARATOR | Rebamipide 2% |
| 3 | NO_INTERVENTION | placebo |
| Name | Type | Description |
|---|---|---|
| Rebamipide | DRUG | 1. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks 2. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks |
Inclusion Criteria: * must have symptoms of dry eye for a minimum of 6 months * must be able to sign and date an informed consent Exclusion Criteria: * presence of anterior segment disease * glaucoma or ocular hypertension * using Restasis * use of topically instilled ocular medications during st...