Clinical trial NCT03494504: ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: reproxalap
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-11
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Subject-reported Ocular Itching Score
timeFrame: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Secondary outcomes:
measure: Number of Subjects With Two-point Reduction in Itching Score
timeFrame: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea Consultants of Arizon
state: Arizona
city: Sacramento
country: United States
facility: Eye Site Sacramento
state: California
city: Torrance
country: United States
facility: East West Eye Institute
state: California
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: San Antonio
country: United States
facility: Eye Clinics of South Texas
state: Texas
city: San Antonio
country: United States
facility: R & R Research, LLC
state: Texas
Study officials:
References: