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

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Loteprednol etabonate suspension; Drug: Loteprednol etabonate base (QD); Drug: Loteprednol etabonate base (BID); Drug: Loteprednol etabonate base (QID); Drug: Vehicle of loteprednol etabonate

• Registration Number: NCT01107405
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-21
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Results First Submitted: 2011-09-21
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-14
• Last Update Submitted: 2012-02-14
• Results First Posted: 2012-03-21
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol etabonate suspension (QID)	Loteprednol etabonate suspension	Loteprednol etabonate ophthalmic suspension dosed four times/day
Loteprednol etabonate base (QD)	Loteprednol etabonate base (QD)	Loteprednol etabonate ophthalmic base dosed once/day.
Loteprednol etabonate base (BID)	Loteprednol etabonate base (BID)	Loteprednol etabonate ophthalmic base dosed two times/day
Loteprednol etabonate base (QID)	Loteprednol etabonate base (QID)	Loteprednol etabonate ophthalmic base dosed four times/day.
Vehicle of loteprednol etabonate	Vehicle of loteprednol etabonate	Vehicle of loteprednol etabonate, dosed either QD, BID, or QID

Primary Outcome Measures

Name	Time	Method
Ocular Itching	Visit 4 (8 hr re-challenge)	Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Conjunctival Redness	Visit 4 (8 hr re-challenge)	Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

Secondary Outcome Measures

Name	Time	Method
Ocular Itching	Visit 4 (initial challenge)	Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Conjunctival Redness	Visit 4 (initial challenge)	Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States