Conditions: Allergic Conjunctivitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 101
Healthy volunteers: no

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:

Arms:
arm 1: Loteprednol etabonate ophthalmic base dosed once/day. arm 2: Loteprednol etabonate ophthalmic base dosed two times/day arm 3: Loteprednol etabonate ophthalmic base dosed four times/day. arm 4: Loteprednol etabonate ophthalmic suspension dosed four times/day arm 5: Vehicle of loteprednol etabonate, dosed either QD, BID, or QID

Interventions: intervention 1: Loteprednol etabonate base (QD) intervention 2: Loteprednol etabonate base (BID) intervention 3: Loteprednol etabonate base (QID) intervention 4: Loteprednol etabonate suspension intervention 5: Vehicle of loteprednol etabonate
Intervention descriptions: intervention 1: Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks intervention 2: Loteprednol etabonate ophthalmic base BID dosing for 2 weeks intervention 3: Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week intervention 4: Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks. intervention 5: Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

Protocol document: