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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01736527 | Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation | PHASE1 | COMPLETED | 12 | — | — | Jan 1, 2013 | Apr 1, 2013 | Nov 8, 2013 | 1 | United States |
Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose
| Arm | Type | Description |
|---|---|---|
| LE Gel | EXPERIMENTAL | A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears. |
| Name | Type | Description |
|---|---|---|
| LE Gel | DRUG | Single drop of LE Gel 0.5% administered to the study eye on visit 2 |
Inclusion Criteria: * Subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * Subjects must have a best-corrected visual acuity of 20/20 or better in each eye. * Subjects must have no active ocular disease or ...