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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494504
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494504


Locations
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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.

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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03494504     History of Changes
Other Study ID Numbers: ADX-102-AC-008
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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