Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.

Last updated: March 13, 2024
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

3

Condition

Allergy (Pediatric)

Allergies & Asthma

Allergy

Treatment

Ketotifen/naphazoline

Naphazoline

Vehicle

Clinical Study ID

NCT00769886
571
  • Ages > 6
  • All Genders

Study Summary

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Positive history of ocular allergies and positive skin test reaction to cat hair, catdander, grasses, ragweed, and/or trees within the past 24 months.
  • Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye asmeasured using the ETDRS chart.
  • Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes ofinstillation of the last titration of allergen at visit 1.
  • Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.

Exclusion

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 thesubjects safety or trial parameters.
  • Use of disallowed medications during the period indicated prior to study enrollment orduring the study.

Study Design

Total Participants: 144
Treatment Group(s): 4
Primary Treatment: Ketotifen/naphazoline
Phase: 3
Study Start date:
October 01, 2008
Estimated Completion Date:
June 30, 2009

Connect with a study center

  • Ophthalmic Research Consultants, Inc.

    North Andover, Massachusetts 01845
    United States

    Site Not Available

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