An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease

Dry Eye Clinical Trial

Official title:

An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects With Dry Eye Disease in a Dry Eye Chamber

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102409
• Other study ID #: ADX-102-DED-025
• Status: Completed
• Phase: Phase 2
• Start date: September 9, 2021
• Est. completion date: October 25, 2021

Study information

• Verified date: October 2021
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Eighteen (18) to70 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 Visit 1.

Exclusion Criteria:

1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1.

2. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial.

3. 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.

4. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) dosed once
• Xiidra® (5% lifitegrast ophthalmic solution)
Xiidra® (5% lifitegrast ophthalmic solution) dosed once

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	Adverse Event (AE) Query	Collection of AEs during the trial	Through trial completion, approximately four weeks