Reproxalap Activity and Estimation of Clinically Relevant Thresholds for Ocular Itching and Redness in a Randomized Allergic Conjunctivitis Field Trial

Introduction This clinical trial assessed the activity of reproxalap, a novel reactive aldehyde species modulator, and estimated clinically relevant thresholds for changes in ocular itching and redness in an allergic conjunctivitis field trial. Methods This was a randomized, double-masked, vehicle-c...

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Bibliographic Details
Published in:Ophthalmology and therapy 2022-08, Vol.11 (4), p.1449-1461
Main Authors: Cavanagh, Bill, Gomes, Paul J., Starr, Christopher E., Nichols, Kelly K., Brady, Todd C.
Format: Article
Language:English
Subjects:
Internal Medicine
Medicine
Medicine & Public Health
Ophthalmology
Original Research
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Summary:Introduction This clinical trial assessed the activity of reproxalap, a novel reactive aldehyde species modulator, and estimated clinically relevant thresholds for changes in ocular itching and redness in an allergic conjunctivitis field trial. Methods This was a randomized, double-masked, vehicle-controlled phase 2 trial. Patients with ragweed-associated allergic conjunctivitis were assessed over 28 days in an environmental setting with approximately four doses per day of either 0.25% reproxalap, 0.5% reproxalap, or vehicle. Patients recorded ocular itching, redness, tearing, and eyelid swelling scores (each with a 0–4 scale, except for a 0–3 scale for swelling), and completed the Allergic Conjunctivitis Quality of Life Questionnaire at the beginning and end of the trial. Results Mixed model of repeated measures analysis demonstrated statistically lower itching and tearing scores (pooled P  = 0.026 and P  
ISSN:2193-8245
2193-6528
DOI:10.1007/s40123-022-00520-z