A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

NCT03404115 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-102-DED-009
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Dry Eye Syndrome

Keywords

reproxalap

Outcome Measures

Primary Outcomes (1)

• Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.

  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.

  Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.

Study Arms (3)

Reproxalap Ophthalmic Solution (0.25%)

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.1%)

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.1%)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.1%) DRUG

Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.

Reproxalap Ophthalmic Solution (0.1%)

Vehicle Ophthalmic Solution DRUG

Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Vehicle Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age of either gender and any race;
• Have a reported history of dry eye for at least 6 months prior to Visit 1;
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

You may not qualify if:

• Have any 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;
• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
• Have used any eye drops within 2 hours of Visit 1;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;
• Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
• Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (6)

The Eye Care Group

Waterbury, Connecticut, 06708, United States

Location

Midwest Cornea Associates

Indianapolis, Indiana, 46290, United States

Location

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Andover Eye Associates

Raynham, Massachusetts, 02767, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Related Publications (1)

• Clark D, Sheppard J, Brady TC. A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease. J Ocul Pharmacol Ther. 2021 May;37(4):193-199. doi: 10.1089/jop.2020.0087. Epub 2021 Jan 15.

  PMID: 33450164 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: January 2, 2018
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2018
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)