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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494504
• Other study ID #: ADX-102-AC-008
• Status: Completed
• Phase: Phase 3
• Start date: March 30, 2018
• Est. completion date: November 5, 2018

Study information

• Verified date: April 2018
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: November 5, 2018
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered once.
• Reproxalap Ophthalmic Solution (0.5%)
Reproxalap Ophthalmic Solution (0.5%) administered once.
• Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution administered once.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Seidenberg Protzko Eye Associates	Havre De Grace	Maryland
United States	Cornea Consultants of Arizon	Phoenix	Arizona
United States	Eye Site Sacramento	Sacramento	California
United States	Eye Clinics of South Texas	San Antonio	Texas
United States	R & R Research, LLC	San Antonio	Texas
United States	East West Eye Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular itching evaluated by the Subject.	The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale	Efficacy assessment period (Day -21 through Day 1)
Secondary	Conjunctival redness	The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale	Efficacy assessment period (Day -21 through Day 1)