Allergic Conjunctivitis Clinical Trial
Official title:
A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model
NCT number | NCT00534794 |
Other study ID # | 031-408 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | September 20, 2007 |
Last updated | April 27, 2015 |
Start date | October 2007 |
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.
Status | Completed |
Enrollment | 79 |
Est. completion date | |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 0 hours, 12 hours | No |
Secondary | Ocular Comfort Score at 12 Hours | Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale. | 12 hours | No |
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