Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LE · 1 trial · 1 indication
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 ...
LE is an investigational small molecule being developed by Bausch + Lomb Corporation (BLCO) for pharmacokinetics. It is currently in Phase 1 clinical development. As an investigational drug, it has not been approved by the FDA and remains under study.
LE is being studied for pharmacokinetics, meaning the clinical trial focuses on how the drug is absorbed, distributed, metabolized, and excreted in the body. The specific indication is pharmacokinetics, and the study involves healthy volunteers.
LE is being developed by Bausch + Lomb Corporation, a company traded under the ticker BLCO. The company is conducting clinical research on this investigational small molecule drug.
LE is in Phase 1 clinical development. The single completed trial, NCT01736527, was a Phase 1 study. The drug remains investigational and has not been approved by regulatory authorities.
LE has one completed clinical trial, NCT01736527, titled "Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation." This Phase 1 study enrolled 12 participants in the United States and was uncontrolled, not randomized, and not double-blind.