Status:
COMPLETED
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief 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 o...
Eligibility Criteria
Inclusion
- Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
- Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
- Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation 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
- Known contraindications or sensitivities to the study medication or its components.
- Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
- Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00770133
Start Date
February 1 2010
End Date
June 1 2010
Last Update
October 27 2020
Active Locations (1)
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1
Ophthalmic Research Consultants, Inc.
North Andover, Massachusetts, United States, 01845