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

Aldeyra Therapeutics, Inc.131 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

131

Conditions

Allergic Conjunctivitis

Interventions

Reproxalap Ophthalmic Solution (0.25%)DRUG

Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Vehicle Ophthalmic SolutionDRUG

Vehicle Ophthalmic Solution dosed twice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber

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.

Time frame: 110 to 210 minutes during allergen chamber exposure

Secondary Outcomes

Conjunctival Redness Evaluated by the Investigator

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.

Time frame: 12 to 212 minutes during allergen chamber exposure

Data from ClinicalTrials.gov

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