Back to resultsA Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 1
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
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 ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
- 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 any of the investigational product medication or 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 months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
- have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
- have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
- be a female who is currently pregnant, planning a pregnancy, or lactating
Sites / Locations
- Slade & Baker Vision
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, safety, and tolerability.
The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale.
Secondary Outcome Measures
Adverse event assessment.
Collection of adverse events.
Full Information
NCT ID
NCT03660878
First Posted
August 31, 2018
Last Updated
December 2, 2020
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03660878
Brief Title
A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis
Official Title
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial With Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 8, 2018 (Actual)
Primary Completion Date
November 19, 2019 (Actual)
Study Completion Date
November 19, 2019 (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, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (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 four times a day and an additional four times a day on an as needed basis.
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.5%)
Intervention Description
Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution
Intervention Description
Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.
Primary Outcome Measure Information:
Title
Ocular itching evaluated by the Subject, safety, and tolerability.
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 1 through Day 29)
Secondary Outcome Measure Information:
Title
Adverse event assessment.
Description
Collection of adverse events.
Time Frame
Safety assessment period (Day 1 through Day 29)
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 ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
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 any of the investigational product medication or 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 months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
be a female who is currently pregnant, planning a pregnancy, or lactating
Facility Information:
Facility Name
Slade & Baker Vision
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis
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