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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Loteprednol etabonate base (QD)

Loteprednol etabonate ophthalmic base dosed once/day.

Group Type ACTIVE_COMPARATOR

Loteprednol etabonate base (QD)

Intervention Type DRUG

Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks

Loteprednol etabonate base (BID)

Loteprednol etabonate ophthalmic base dosed two times/day

Group Type ACTIVE_COMPARATOR

Loteprednol etabonate base (BID)

Intervention Type DRUG

Loteprednol etabonate ophthalmic base BID dosing for 2 weeks

Loteprednol etabonate base (QID)

Loteprednol etabonate ophthalmic base dosed four times/day.

Group Type ACTIVE_COMPARATOR

Loteprednol etabonate base (QID)

Intervention Type DRUG

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

Loteprednol etabonate suspension (QID)

Loteprednol etabonate ophthalmic suspension dosed four times/day

Group Type ACTIVE_COMPARATOR

Loteprednol etabonate suspension

Intervention Type DRUG

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

Vehicle of loteprednol etabonate

Vehicle of loteprednol etabonate, dosed either QD, BID, or QID

Group Type PLACEBO_COMPARATOR

Vehicle of loteprednol etabonate

Intervention Type DRUG

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

Interventions

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Loteprednol etabonate base (QD)

Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks

Intervention Type DRUG

Loteprednol etabonate base (BID)

Loteprednol etabonate ophthalmic base BID dosing for 2 weeks

Intervention Type DRUG

Loteprednol etabonate base (QID)

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

Intervention Type DRUG

Loteprednol etabonate suspension

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

Intervention Type DRUG

Vehicle of loteprednol etabonate

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.

Exclusion Criteria

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No