ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

• ClinicalTrials.gov Identifier: NCT03494504
• Recruitment Status: Completed
• First Posted: April 11, 2018
• Last Update Posted: November 6, 2019
• Sponsor: Aldeyra Therapeutics, Inc.
• Information provided by (Responsible Party): Aldeyra Therapeutics, Inc.

Study Description

Brief Summary:

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis

Condition or disease	Intervention/treatment	Phase
Allergic Conjunctivitis	Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Reproxalap Ophthalmic Solution (0.5%); Drug: Vehicle Ophthalmic Solution	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 318 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis
• Actual Study Start Date: March 30, 2018
• Actual Primary Completion Date: November 5, 2018
• Actual Study Completion Date: November 5, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%)	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered once.
Experimental: Reproxalap Ophthalmic Solution (0.5%)	Drug: Reproxalap Ophthalmic Solution (0.5%); Reproxalap Ophthalmic Solution (0.5%) administered once.
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution administered once.

Outcome Measures

Primary Outcome Measures :

1. Ocular itching evaluated by the Subject. [ Time Frame: Efficacy assessment period (Day -21 through Day 1) ]
   The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale

Secondary Outcome Measures :

1. Conjunctival redness [ Time Frame: Efficacy assessment period (Day -21 through Day 1) ]
   The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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 a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
• have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

Exclusion Criteria:

• have known contraindications or sensitivities to the use of the investigational product or any of its 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 (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
• have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
• have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
• be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1

Contacts and Locations

Locations

United States, Arizona

Cornea Consultants of Arizon

Phoenix, Arizona, United States, 85032

United States, California

Eye Site Sacramento

Sacramento, California, United States, 95819

East West Eye Institute

Torrance, California, United States, 90505

United States, Maryland

Seidenberg Protzko Eye Associates

Havre De Grace, Maryland, United States, 21078

United States, Massachusetts

Andover Eye Associates

Andover, Massachusetts, United States, 01810

United States, Texas

Eye Clinics of South Texas

San Antonio, Texas, United States, 78209

R & R Research, LLC

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Aldeyra Therapeutics, Inc.

More Information

• Responsible Party: Aldeyra Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03494504
• Other Study ID Numbers: ADX-102-AC-008
• First Posted: April 11, 2018
• Last Update Posted: November 6, 2019
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aldeyra Therapeutics, Inc.:

reproxalap

Additional relevant MeSH terms:

Conjunctivitis; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pharmaceutical Solutions; Ophthalmic Solutions