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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00534794
First received: September 20, 2007
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Elestat
Drug: Pataday
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Ocular Itch Score From Baseline [ Time Frame: 0 hours, 12 hours ] [ Designated as safety issue: No ]
    Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.


Secondary Outcome Measures:
  • Ocular Comfort Score at 12 Hours [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.


Enrollment: 79
Study Start Date: October 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elestat Drug: Elestat
Elestat BID for 2 days
Active Comparator: Pataday Drug: Pataday
Pataday QD for 2 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00534794

Locations
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Michael Raizman, MD Ophthalmic Consultants of Boston
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00534794     History of Changes
Other Study ID Numbers: 031-408
Study First Received: September 20, 2007
Results First Received: January 30, 2009
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 29, 2014