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

Last updated: October 5, 2020
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Allergy (Pediatric)

Allergy

Treatment

N/A

Clinical Study ID

NCT00770133
572
  • 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 for 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: 141
Study Start date:
February 01, 2010
Estimated Completion Date:
June 30, 2010

Connect with a study center

  • Ophthalmic Research Consultants, Inc.

    North Andover, Massachusetts 01845
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.