A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424549
• Other study ID #: ADX-102-DED-027
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

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