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Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

NCT01107405 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2012-03-21

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.

Conditions

  • Allergic Conjunctivitis

Interventions

DRUG

Loteprednol etabonate base (QD)

Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks

DRUG

Loteprednol etabonate base (BID)

Loteprednol etabonate ophthalmic base BID dosing for 2 weeks

DRUG

Loteprednol etabonate base (QID)

Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week

DRUG

Loteprednol etabonate suspension

Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.

DRUG

Vehicle of loteprednol etabonate

Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Tuyen Ong, MD · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-05-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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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 NCT01107405 on ClinicalTrials.gov