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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution; Drug: Reproxalap Ophthalmic Solution (0.5%)

• Registration Number: NCT03494504
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-30
• Status Verified: 2018-04
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Primary Completion: 2018-11-05
• Study Completion: 2018-11-05
• Disposition First Submitted: 2019-10-30
• Disposition First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-30
• Disposition First Posted: 2019-11-06
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-
Reproxalap Ophthalmic Solution (0.5%)	Reproxalap Ophthalmic Solution (0.5%)	-

Primary Outcome Measures

Name	Time	Method
Ocular itching evaluated by the Subject.	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

Name	Time	Method
Conjunctival redness	Efficacy assessment period (Day -21 through Day 1)	The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale

Trial Locations

Locations (7)

Eye Clinics of South Texas; 🇺🇸 San Antonio, Texas, United States

R & R Research, LLC; 🇺🇸 San Antonio, Texas, United States

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States

Cornea Consultants of Arizon; 🇺🇸 Phoenix, Arizona, United States

Seidenberg Protzko Eye Associates; 🇺🇸 Havre De Grace, Maryland, United States

East West Eye Institute; 🇺🇸 Torrance, California, United States

Eye Site Sacramento; 🇺🇸 Sacramento, California, United States