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): 66
• 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
• Genders Eligible for Study: All

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
Ocular itching evaluated by the Subject.	The method of assessment for this exploratory outcome includes the visual analog scale (VAS).	Efficacy assessment period (Week 1 through Week 6).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment.	Safety assessment as determined by collection of Adverse Events	Safety assessment period (Week 1 through week 6)

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): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

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