Reproxalap ophthalmic solution (0.25%)
DrugReproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
NCT Number: NCT03404115
A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease
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Notify Me18 year and older
All sexes
Interventional
Phase 2
The Eye Care Group, Waterbury, Connecticut, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
Vehicle Ophthalmic Solution administered for approximately twelve weeks.
Time frame: Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort & 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
Aldeyra Therapeutics, Inc.
Industry
A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) 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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