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The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis | Clinical Trials | Clareo Health

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The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

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)

NCT05234554•Aldeyra Therapeutics, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Cliantha Research

Mississauga, Ontario, Canada

Key Dates

Start Date

January 21, 2022

Primary Completion Date

April 22, 2023

Completion Date

April 22, 2023

Last Updated

April 18, 2024

Enrollment

131

ACTUAL participants

Conditions

Allergic Conjunctivitis

Interventions

Reproxalap Ophthalmic Solution (0.25%)

DRUG

Vehicle Ophthalmic Solution

DRUG

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

NCT05839938

Allergic Conjunctivitis

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Allergic Rhinitis Due to PollenAllergic Conjunctivitis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

Inclusion Criteria

Exclusion Criteria

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

Tyrosine Allergoid Paediatric and Adult Study

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