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

Bausch + Lomb

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Loteprednol etabonate base (QID); Drug: Loteprednol etabonate base (BID); Drug: Loteprednol etabonate base (QD); Drug: Loteprednol etabonate suspension; Drug: Vehicle of loteprednol etabonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107405

584

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 5 patient groups, including a placebo group

Loteprednol etabonate base (QD)

Active Comparator group

Description:

Loteprednol etabonate ophthalmic base dosed once/day.

Treatment:

Drug: Loteprednol etabonate base (QD)

Loteprednol etabonate base (BID)

Active Comparator group

Description:

Loteprednol etabonate ophthalmic base dosed two times/day

Treatment:

Drug: Loteprednol etabonate base (BID)

Loteprednol etabonate base (QID)

Active Comparator group

Description:

Loteprednol etabonate ophthalmic base dosed four times/day.

Treatment:

Drug: Loteprednol etabonate base (QID)

Loteprednol etabonate suspension (QID)

Active Comparator group

Description:

Loteprednol etabonate ophthalmic suspension dosed four times/day

Treatment:

Drug: Loteprednol etabonate suspension

Vehicle of loteprednol etabonate

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle of loteprednol etabonate