NCT03098953

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bausch & Lomb Incorporated · 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

Detailed description

This will be a single-center, single-arm, open label PK clinical study of loteprednol etabonate (LE) ophthalmic gel, 0.38% conducted at one clinical center in the United States (US), with the goal of enrolling approximately 15 healthy normal subjects in the treatment period

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Loteprednol Etabonate	one drop per eye for each eye

Timeline

• Start date: 2017-04-10
• Primary completion: 2017-05-12
• Completion: 2017-05-12
• First posted: 2017-04-04
• Last updated: 2017-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study