ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.5%)
Vehicle Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring reproxalap
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
Sites / Locations
- Cornea Consultants of Arizon
- Eye Site Sacramento
- East West Eye Institute
- Seidenberg Protzko Eye Associates
- Andover Eye Associates
- Eye Clinics of South Texas
- R & R Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.5%)
Vehicle Ophthalmic Solution
Arm Description
Outcomes
Primary Outcome Measures
Ocular itching evaluated by the Subject.
The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale
Secondary Outcome Measures
Conjunctival redness
The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale
Full Information
NCT ID
NCT03494504
First Posted
April 4, 2018
Last Updated
October 30, 2019
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03494504
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
November 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
reproxalap
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reproxalap Ophthalmic Solution (0.25%)
Arm Type
Experimental
Arm Title
Reproxalap Ophthalmic Solution (0.5%)
Arm Type
Experimental
Arm Title
Vehicle Ophthalmic Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.25%)
Intervention Description
Reproxalap Ophthalmic Solution (0.25%) administered once.
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.5%)
Intervention Description
Reproxalap Ophthalmic Solution (0.5%) administered once.
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution
Intervention Description
Vehicle Ophthalmic Solution administered once.
Primary Outcome Measure Information:
Title
Ocular itching evaluated by the Subject.
Description
The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale
Time Frame
Efficacy assessment period (Day -21 through Day 1)
Secondary Outcome Measure Information:
Title
Conjunctival redness
Description
The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale
Time Frame
Efficacy assessment period (Day -21 through Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cornea Consultants of Arizon
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Eye Site Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
East West Eye Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Seidenberg Protzko Eye Associates
City
Havre De Grace
State/Province
Maryland
ZIP/Postal Code
21078
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Eye Clinics of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
R & R Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
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