Cliantha Research
Mississauga, Ontario, L4W 1A4, Canada
NCT Number: NCT05424549
A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Mississauga, Ontario, L4W 1A4, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days
Vehicle Ophthalmic Solution dosed six times over two consecutive days
Time frame: The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.
Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.
Time frame: The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period.
Change from baseline comparison of reproxalap to vehicle for schirmer test on a millimeter line (0 = none, 35 = maximum). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.
Aldeyra Therapeutics, Inc.
Industry
A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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