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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03494504

Collaborator

(none)

318

Enrollment

Locations

Arms

7.2

Actual Duration (Months)

45.4

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

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

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 :

Mar 30, 2018

Actual Primary Completion Date :

Nov 5, 2018

Actual Study Completion Date :

Nov 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.

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Cornea Consultants of Arizon	Phoenix	Arizona	United States	85032
2	Eye Site Sacramento	Sacramento	California	United States	95819
3	East West Eye Institute	Torrance	California	United States	90505
4	Seidenberg Protzko Eye Associates	Havre De Grace	Maryland	United States	21078
5	Andover Eye Associates	Andover	Massachusetts	United States	01810
6	Eye Clinics of South Texas	San Antonio	Texas	United States	78209
7	R & R Research, LLC	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aldeyra Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT03494504

Other Study ID Numbers:

ADX-102-AC-008

First Posted:

Apr 11, 2018

Last Update Posted:

Nov 6, 2019

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aldeyra Therapeutics, Inc.

reproxalap

Additional relevant MeSH terms:

Conjunctivitis

Conjunctivitis, Allergic

Pharmaceutical Solutions

Ophthalmic Solutions

Study Results

No Results Posted as of Nov 6, 2019