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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01028027 | Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis | PHASE3 | COMPLETED | 357 | — | — | Oct 1, 2009 | Mar 1, 2010 | Feb 28, 2012 | 1 | Singapore |
The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).
| Arm | Type | Description |
|---|---|---|
| Loteprednol and tobramycin | EXPERIMENTAL | Loteprednol etabonate and tobramycin ophthalmic suspension |
| Tobramycin and dexamethasone | ACTIVE_COMPARATOR | Tobramycin and dexamethasone ophthalmic suspension |
| Name | Type | Description |
|---|---|---|
| Loteprednol and tobramycin | DRUG | Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days. |
| Tobramycin and dexamethasone | DRUG | Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days. |
Inclusion Criteria: * Subjects must have a clinical diagnosis of BKC in at least one eye * Subjects must be willing to discontinue contact lens use for the duration of the study * Subjects who are able and willing to comply with all treatment and follow- up/study procedures. Exclusion Criteria: *...