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

Completed · Phase 2

Conditions studied: Allergic Conjunctivitis

In brief

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.

Key facts

Study ID

NCT01107405

Run by

Bausch & Lomb Incorporated

People needed

101

Starts

2010-04-01

Expected to finish

2010-08-01

Last updated by the study team

2012-03-21

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch & Lomb — Rochester, New York, United States

Full record on ClinicalTrials.gov

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