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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05424549
Other study ID # ADX-102-DED-027
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 9, 2022
Est. completion date May 9, 2022

Study information

Verified date June 2022
Source Aldeyra Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date May 9, 2022
Est. primary completion date May 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Eighteen (18) to 70 years of age at the time of screening (either gender and any race) 2. Ability to provide written informed consent 3. Reported history of dry eye for at least 6 months prior to screening 4. Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening Exclusion Criteria: 1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening 2. Contact lens use within 7 days of screening or anticipate using contact lenses during the trial 3. Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period 4. Women of childbearing potential (WOCBP) who are pregnant and nursing 5. If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control. 6. Known allergy and/or sensitivity to reproxalap or the drug product vehicle 7. A condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial 8. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits

Study Design


Intervention

Drug:
Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days
Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed six times over two consecutive days

Locations

Country Name City State
Canada Cliantha Research Mississauga Ontario

Sponsors (1)

Lead Sponsor Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in conjunctival redness in a dry eye chamber Conjunctival redness assessed on a 9 point scale using half unit increments using the modified Validated Bulbar Redness scale (0 None (better) - 4 Extremely Severe (worse)) On the second day of two consecutive dosing days for both crossover periods
Primary Schirmer's test mean change from baseline Assessed using a sterile Schirmer's test strip On the first day of two consecutive dosing days for both crossover periods
Secondary Schirmer's test =10mm responder analysis of change from baseline Assessed using a sterile Schirmer's test strip On the first day of two consecutive dosing days for both crossover periods
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