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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03063489 | Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability | PHASE1 | COMPLETED | 15 | — | — | Feb 1, 2015 | Jul 1, 2015 | Feb 24, 2017 | 6 | United States |
| Arm | Type | Description |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel | EXPERIMENTAL | Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\]) |
| Name | Type | Description |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel | DRUG | Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\]) |
Key Inclusion Criteria: * Are able to read, understand and provide written informed consent on an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). * Be a non-smoking male or female at least 18 years of age on the date the ICF is signed...