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

NCT ID: NCT03709121

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2019-03-20

Brief Summary

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)

Conditions

Conjunctivitis, Allergic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Reproxalap Ophthalmic Solution (0.25%)

Group Type: EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.25%)

Intervention Type: DRUG

Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Reproxalap Ophthalmic Solution (0.5%)

Group Type: EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.5%)

Intervention Type: DRUG

Reproxalap Ophthalmic Solution (0.5%) dosed twice.

Vehicle Ophthalmic Solution

Group Type: PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type: DRUG

Vehicle Ophthalmic Solution dosed twice.

Interventions

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Intervention Type: DRUG

Reproxalap Ophthalmic Solution (0.5%)

Reproxalap Ophthalmic Solution (0.5%) dosed twice.

Intervention Type: DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution dosed twice.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inflamax Research Limited

Mississauga, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ADX-102-AC-011

Identifier Type: -

Identifier Source: org_study_id