Back to resultsStudy of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Elestat
Pataday
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility 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.
Sites / Locations
- Ophthalmic Consultants of Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Elestat
Pataday
Arm Description
Outcomes
Primary Outcome Measures
Change in Ocular Itch Score From Baseline
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
Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.
Full Information
NCT ID
NCT00534794
First Posted
September 20, 2007
Last Updated
April 27, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00534794
Brief Title
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
Official Title
A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elestat
Arm Type
Experimental
Arm Title
Pataday
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Elestat
Intervention Description
Elestat BID for 2 days
Intervention Type
Drug
Intervention Name(s)
Pataday
Intervention Description
Pataday QD for 2 days
Primary Outcome Measure Information:
Title
Change in Ocular Itch Score From Baseline
Description
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.
Time Frame
0 hours, 12 hours
Secondary Outcome Measure Information:
Title
Ocular Comfort Score at 12 Hours
Description
Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Raizman, MD
Organizational Affiliation
Ophthalmic Consultants of Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
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