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

Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model

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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Loteprednol etabonate base (QD); Drug: Loteprednol etabonate base (BID); Drug: Loteprednol etabonate base (QID); Drug: Loteprednol etabonate suspension; Drug: Vehicle of loteprednol etabonate

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14603
      • Bausch & Lomb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Loteprednol etabonate base (QD); Loteprednol etabonate ophthalmic base dosed once/day.	Drug: Loteprednol etabonate base (QD); Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks
Active Comparator: Loteprednol etabonate base (BID); Loteprednol etabonate ophthalmic base dosed two times/day	Drug: Loteprednol etabonate base (BID); Loteprednol etabonate ophthalmic base BID dosing for 2 weeks
Active Comparator: Loteprednol etabonate base (QID); Loteprednol etabonate ophthalmic base dosed four times/day.	Drug: Loteprednol etabonate base (QID); Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week
Active Comparator: Loteprednol etabonate suspension (QID); Loteprednol etabonate ophthalmic suspension dosed four times/day	Drug: Loteprednol etabonate suspension; Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.
Placebo Comparator: Vehicle of loteprednol etabonate; Vehicle of loteprednol etabonate, dosed either QD, BID, or QID	Drug: Vehicle of loteprednol etabonate; Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Itching	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.	Visit 4 (8 hr re-challenge)
Conjunctival Redness	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.	Visit 4 (8 hr re-challenge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Itching	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.	Visit 3 (initial challenge)
Conjunctival Redness	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.	Visit 3 (initial challenge)
Ocular Itching	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.	Visit 4 (initial challenge)
Conjunctival Redness	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.	Visit 4 (initial challenge)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 21, 2010

Study Record Updates

• Last Update Posted (Estimate): March 21, 2012
• Last Update Submitted That Met QC Criteria: February 14, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: 584