Back to resultsA Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber
Primary Purpose
Conjunctivitis, Allergic
Status
Completed
Phase
Phase 1
Locations
Canada
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 Conjunctivitis, Allergic focused on measuring reproxalap, ADX-102, allergic conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- be at least 18 years of age of either gender and any race
- have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
- have a positive skin prick test to ragweed pollen within the past year of screening
Exclusion Criteria:
- known contraindication or hypersensitivities to any components of the investigational product medication or components
- history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
- presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
- diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
- woman of childbearing potential who is pregnant or nursing
Sites / Locations
- Inflamax Research Limited
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 exploratory outcome includes the visual analog scale (VAS).
Secondary Outcome Measures
Safety assessment.
Safety assessment as determined by collection of Adverse Events
Full Information
NCT ID
NCT03709121
First Posted
October 3, 2018
Last Updated
May 11, 2020
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03709121
Brief Title
A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber
Official Title
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Allergic
Keywords
reproxalap, ADX-102, allergic conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (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%) dosed twice.
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.5%)
Intervention Description
Reproxalap Ophthalmic Solution (0.5%) dosed twice.
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution
Intervention Description
Vehicle Ophthalmic Solution dosed twice.
Primary Outcome Measure Information:
Title
Ocular itching evaluated by the Subject.
Description
The method of assessment for this exploratory outcome includes the visual analog scale (VAS).
Time Frame
Efficacy assessment period (Week 1 through Week 6).
Secondary Outcome Measure Information:
Title
Safety assessment.
Description
Safety assessment as determined by collection of Adverse Events
Time Frame
Safety assessment period (Week 1 through week 6)
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 at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
have a positive skin prick test to ragweed pollen within the past year of screening
Exclusion Criteria:
known contraindication or hypersensitivities to any components of the investigational product medication or components
history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
woman of childbearing potential who is pregnant or nursing
Facility Information:
Facility Name
Inflamax Research Limited
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1V7/L4W 1N2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber
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