CompletedPhase 3

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

Canada131 participantsStarted 2022-01-21

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber

Timeframe: 110 to 210 minutes during allergen chamber exposure

Trial details

NCT IDNCT05234554

SponsorAldeyra Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-22

Results submitted2026-04-02

View on ClinicalTrials.gov More Allergic Conjunctivitis trials