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

NCT05234554 | Completed Phase 3 FDA Drug

• 1 other identifier: ADX-102-AC-026
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Ocular itching evaluated by the Subject.

  The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe).

  During EEC allergen exposure.

Secondary Outcomes (1)

• Conjunctival redness evaluated by the Subject.

  During EEC allergen exposure.

Study Arms (2)

Reproxalap Ophthalmic Solution (0.25%)

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution DRUG

Vehicle Ophthalmic Solution dosed twice.

Vehicle Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: January 21, 2022
• Primary Completion: April 22, 2023
• Study Completion: April 22, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)