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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01107405
First Posted: April 21, 2010
Last Update Posted: March 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
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.

Condition Intervention Phase
Allergic Conjunctivitis Drug: Loteprednol etabonate base (QD) Drug: Loteprednol etabonate base (BID) Drug: Loteprednol etabonate base (QID) Drug: Loteprednol etabonate suspension Drug: Vehicle of loteprednol etabonate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 101
Study Start Date: April 2010
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107405


Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14603
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tuyen Ong, MD Bausch & Lomb Incorporated
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01107405     History of Changes
Other Study ID Numbers: 584
First Submitted: April 15, 2010
First Posted: April 21, 2010
Results First Submitted: September 21, 2011
Results First Posted: March 21, 2012
Last Update Posted: March 21, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loteprednol Etabonate
Anti-Allergic Agents