A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis

NCT03660878 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ADX-102-AC-010
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Ocular Itching Score on High Pollen Days

  Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.

  Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.

Study Arms (3)

Reproxalap Ophthalmic Solution (0.25%)

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.5%)

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.5%)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.5%) DRUG

Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.

Reproxalap Ophthalmic Solution (0.5%)

Vehicle Ophthalmic Solution DRUG

Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.

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 positive history of ocular allergies and a positive skin test reaction to ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
• have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

You may not qualify if:

• have known contraindications or sensitivities to the use of any of the investigational product medication or components
• have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye)
• have had ocular surgical intervention within three months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
• have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
• have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
• be a female who is currently pregnant, planning a pregnancy, or lactating

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Slade & Baker Vision

Houston, Texas, 77027, United States

Location

Related Publications (1)

• Cavanagh B, Gomes PJ, Starr CE, Nichols KK, Brady TC. Reproxalap Activity and Estimation of Clinically Relevant Thresholds for Ocular Itching and Redness in a Randomized Allergic Conjunctivitis Field Trial. Ophthalmol Ther. 2022 Aug;11(4):1449-1461. doi: 10.1007/s40123-022-00520-z. Epub 2022 May 18.

  PMID: 35585427 RESULT

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System 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 1
• 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: August 31, 2018
• First Posted: September 7, 2018
• Study Start: September 8, 2018
• Primary Completion: November 19, 2019
• Study Completion: November 19, 2019
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)