CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 101 enrolled
Drug / intervention
Loteprednol etabonate base (QD) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01107405
NCT01107405Phase 2Completed
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Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model

Bausch & Lomb Incorporated·interventional·Posted Apr 21, 2010·Updated Mar 21, 2012

In Brief

A Phase 2 clinical trial evaluating Loteprednol etabonate base (QD), Loteprednol etabonate base (BID), and 3 other interventions for Allergic Conjunctivitis. Completed, enrolled 101 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Conjunctivitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 21, 2010
Enrollment StartApr 1, 2010
Primary CompletionMay 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.2 years ago

Interventions

Loteprednol etabonate base (QD)drug

Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks

Loteprednol etabonate base (BID)drug

Loteprednol etabonate ophthalmic base BID dosing for 2 weeks

Loteprednol etabonate base (QID)drug

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

Loteprednol etabonate suspensiondrug

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

Vehicle of loteprednol etabonatedrug

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