A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber

An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)

An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)

Study Overview

• Status: Completed
• Conditions: Conjunctivitis, Allergic
• Intervention / Treatment: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Reproxalap Ophthalmic Solution (0.5%); Drug: Vehicle Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1V7/L4W 1N2
      • Inflamax Research Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• be at least 18 years of age of either gender and any race
• have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
• have a positive skin prick test to ragweed pollen within the past year of screening

Exclusion Criteria:

• known contraindication or hypersensitivities to any components of the investigational product medication or components
• history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
• presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
• presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
• presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
• diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
• woman of childbearing potential who is pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%)	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) dosed twice.
Experimental: Reproxalap Ophthalmic Solution (0.5%)	Drug: Reproxalap Ophthalmic Solution (0.5%); Reproxalap Ophthalmic Solution (0.5%) dosed twice.
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution dosed twice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-Reported Ocular Itching Score	Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.	Efficacy was assessed from 0 to 212 minutes in the allergen chamber.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-Reported Ocular Tearing Score	Change from baseline comparison of reproxalap to vehicle for subject-reported ocular tearing score from 0 to 212 minutes in the allergen chamber using a 4-point scale (0 = none, 3 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.	Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Investigator-Assessed Conjunctival Redness Score	Change from baseline comparison of reproxalap to vehicle for investigator-assessed conjunctival redness from 0 to 210 minutes in the allergen chamber using a 9-point scale with half unit increments (0 = normal, 4 = prominent) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.	Efficacy was assessed from 0 to 210 minutes in the allergen chamber.

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): March 20, 2019

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: reproxalap; allergic conjunctivitis; ADX-102
• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: ADX-102-AC-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes