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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01107405
First received: April 15, 2010
Last updated: February 14, 2012
Last verified: February 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01107405     History of Changes
Other Study ID Numbers: 584
Study First Received: April 15, 2010
Results First Received: September 21, 2011
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loteprednol etabonate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014