A Clinical Trial to Assess Subjects With Dry Eye Disease.

• Sponsor: Aldeyra Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04971031
• Collaborator: (none)
• Enrollment: 158
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 56.6

Study Details

Study Description

Brief Summary

A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
• Actual Study Start Date: Jun 15, 2021
• Actual Primary Completion Date: Sep 8, 2021
• Actual Study Completion Date: Sep 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days.	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days.
Placebo Comparator: Vehicle Ophthalmic Solution administered 7 times over two consecutive days.	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution administered 7 times over two consecutive days.

Outcome Measures

Primary Outcome Measures

1. Conjunctival redness assessed via digital photography over 90 minutes in the dry eye chamber. [Day 2.]

   Conjunctival Redness Scale for Dry Eye on a 0 to 4 scale ( 0 = normal, 4 = .prominent)

Secondary Outcome Measures

1. Change in tear RASP levels after doses of test article. [Day 1 and 2.]

   Tear levels of RASP.

2. Schirmer's Test. [Day 1.]

   Measured using a sterile Schirmer's Test Strip.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years of age (either gender and any race);

2. Reported history of dry eye for at least 6 months prior to Visit 1;

3. Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion Criteria:

1. Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;

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

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

4. Eye drop use within 2 hours of Visit 1;

5. Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;

6. Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;

7. Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;

8. Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;

9. Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aldeyra Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04971031
• Other Study ID Numbers: ADX-102-DED-024
• First Posted: Jul 21, 2021
• Last Update Posted: Dec 9, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Dec 9, 2021