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Completed

NCT Number: NCT01107405

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

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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bausch & Lomb

Rochester, New York, 14603, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Loteprednol etabonate base (QD)

Drug

Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks

Loteprednol etabonate base (BID)

Drug

Loteprednol etabonate ophthalmic base BID dosing for 2 weeks

Loteprednol etabonate base (QID)

Drug

Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week

Loteprednol etabonate suspension

Drug

Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.

Vehicle of Loteprednol Etabonate

Drug

Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

Primary outcomes

  1. Ocular Itching

    Time frame: 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.

  2. Conjunctival Redness

    Time frame: 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 outcomes

  1. Ocular Itching

    Time frame: Visit 3 (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.

  2. Conjunctival Redness

    Time frame: Visit 3 (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.

  3. Ocular Itching

    Time frame: 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.

  4. Conjunctival Redness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 21, 2010
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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