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Completed

NCT Number: NCT05234554

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).

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cliantha Research

Mississauga, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reproxalap ophthalmic solution (0.25%)

Drug

Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Vehicle Ophthalmic Solution

Drug

Vehicle Ophthalmic Solution dosed twice.

Primary outcomes

  1. Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber

    Time frame: 110 to 210 minutes during allergen chamber exposure

    The method of assessment was a 9-point ocular itch scale measured in half-unit increments (0 none - 4 severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 210 ten minutes in duration with the itching assessment being collected every 10 minutes from 110 to 210 minutes. The timepoints were assessed using mixed model repeated measures.

Secondary outcomes

  1. Conjunctival Redness Evaluated by the Investigator

    Time frame: 12 to 212 minutes during allergen chamber exposure

    The method of assessment was a 9-point ocular redness scale measured in half-unit increments (0 none - 4 extremely severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 212 minutes in duration with the redness assessment being collected every 10 minutes from 12 to 212 minutes. The timepoints were assessed using mixed model repeated measures.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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