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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution

• Registration Number: NCT05234554
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-21
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-10
• Primary Completion: 2023-04-22
• Study Completion: 2023-04-22
• Disposition First Posted: 2023-06-18
• Status Verified: 2024-04
• Disposition First Submitted: 2024-04-16
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Ocular itching evaluated by the Subject.	During EEC allergen exposure.	The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe).

Secondary Outcome Measures

Name	Time	Method
Conjunctival redness evaluated by the Subject.	During EEC allergen exposure.	The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none - 4 extremely severe).

Trial Locations

Locations (1)

Cliantha Research; 🇨🇦 Mississauga, Ontario, Canada