Back to resultsThe INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Reproxalap Ophthalmic Solution (0.25%)
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 at the time of screening of either sex or any race;
- Provide written informed consent;
- Be willing and able to follow instructions, and can attend all required clinical trial visits.
- Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;
- Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).
Exclusion Criteria:
- Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
- Have systemic signs of infection (e.g., fever, current treatment with antibiotics).
- Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
- Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;
- Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.
Sites / Locations
- Cliantha Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution
Arm Description
Outcomes
Primary Outcome Measures
Ocular itching evaluated by the Subject.
The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe).
Secondary Outcome Measures
Conjunctival redness evaluated by the Subject.
The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none - 4 extremely severe).
Full Information
NCT ID
NCT05234554
First Posted
February 1, 2022
Last Updated
June 15, 2023
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05234554
Brief Title
The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis
Official Title
The INVIGORATE 2 Trial: A Single-center, Randomized, Double-masked, Crossover Design, Vehicle-controlled, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
April 22, 2023 (Actual)
Study Completion Date
April 22, 2023 (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
The INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle 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
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reproxalap Ophthalmic Solution (0.25%)
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)
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 the primary outcome is a 9-point ocular itch scale (0 none - 4 severe).
Time Frame
During EEC allergen exposure.
Secondary Outcome Measure Information:
Title
Conjunctival redness evaluated by the Subject.
Description
The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none - 4 extremely severe).
Time Frame
During EEC allergen exposure.
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 at the time of screening of either sex or any race;
Provide written informed consent;
Be willing and able to follow instructions, and can attend all required clinical trial visits.
Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;
Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).
Exclusion Criteria:
Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
Have systemic signs of infection (e.g., fever, current treatment with antibiotics).
Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;
Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.
Facility Information:
Facility Name
Cliantha Research
City
Mississauga
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis
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