NCT03063489

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers

Detailed description

The primary objective of this study is to evaluate the systemic pharmacokinetics (PK) of LE (loteprednol etabonate ophthalmic gel), 0.38% in normal healthy volunteer subjects at least 18 years of age and with a normal ophthalmic history. Systemic PK will be assessed in this study after a single dose and after 2 weeks of daily BID dosing.

Conditions

• Eye Pain

Interventions

Type	Name	Description
DRUG	Loteprednol Etabonate Ophthalmic Gel	Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-05-01
• Completion: 2015-07-01
• First posted: 2017-02-24
• Last updated: 2017-02-24

Locations

6 sites across 1 country: United States