MedTrace Logo

Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

NCT01736527 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-11-08

Study results available
· View outcomes & findings →

Summary

To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.

Conditions

  • Pharmacokinetics

Interventions

DRUG

LE Gel

Single drop of LE Gel 0.5% administered to the study eye on visit 2

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Jeffery Schafer, OD, MS · Bausch & Lomb Incorporated

  • Raphaele Siou Mermet, MD, MS · Bausch & Lomb Incorporated

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01736527 on ClinicalTrials.gov