Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis

The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis...

Date First Received: September 20, 2007

Last Updated: May 14, 2008

Verified by: Inspire Pharmaceuticals, May 2008

Clinical Trial Phase: Phase 4 | Start Date: October 2007

Overall Status: Completed

Estimated Enrollment: 80

Brief Summary

Official Title: “A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model”

Condition Keyword(s):

The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.

Study Type: Interventional

Study Design: Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

  • Drug: Epinastine HCl
  • Drug: Olopatadine HCl

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in ocular itch score from baseline
    • Time Frame: 1 day

Secondary Measures

  • Ocular comfort score
    • Time Frame: 1 day

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Documented history of ocular allergy to cats.
  • Positive skin prick allergen reaction to cat dander.

Exclusion Criteria:

  • Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study.
  • History of severe asthma, reactive airway disease or bronchial obstruction.
  • Ocular surgery or trauma in the last year.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Clinical Trial Sponsor Information

Lead Sponsor: Inspire Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Michael Raizman, MD Principal Investigator Ophthalmic Consultants of Boston  

Additional Information

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00534794

Study ID Number: 031-408

ClinicalTrials.gov Identifier: NCT00534794

Health Authority: United States: Institutional Review Board

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