MedTrace Logo

Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

NCT00560638 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2011-07-18

No results posted yet for this study

Summary

This was a single-center, randomized, double-masked, placebo-controlled, parallel-group, 4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose bilaterally either TID or QID according to randomization.

Conditions

  • Dry Eye

Interventions

DRUG

loteprednol etabonate ophthalmic suspension, 0.5%

TID

DRUG

loteprednol etabonate ophthalmic suspension, 0.5%

QID

DRUG

vehicle of loteprednol etabonate

TID or BID according to the randomization

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · Ophthalmic Research Associates, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-02-28
Completion
2006-02-28

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 NCT00560638 on ClinicalTrials.gov