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

• ClinicalTrials.gov Identifier: NCT04207736
• Recruitment Status: Completed
• First Posted: December 23, 2019
• Last Update Posted: January 5, 2022
• Sponsor: Aldeyra Therapeutics, Inc.
• Information provided by (Responsible Party): Aldeyra Therapeutics, Inc.

Study Description

Brief Summary:

The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.

Condition or disease	Intervention/treatment	Phase
Allergic Conjunctivitis	Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution	Phase 3

Detailed Description:

The INVIGORATE Trial: A 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The INVIGORATE Trial: A 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)
• Actual Study Start Date: December 5, 2019
• Actual Primary Completion Date: February 16, 2021
• Actual Study Completion Date: February 16, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Reproxalap Ophthalmic Solution (0.25%)	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.

Outcome Measures

Primary Outcome Measures :

1. Ocular itching evaluated by the Subject. [ Time Frame: 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 :

1. Conjunctival Redness evaluated by the Subject. [ Time Frame: During EEC allergen exposure. ]
   The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none -4 extremely sever).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• be at least 18 years of age of either gender and any race
• have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
• have a positive skin prick test to ragweed pollen within the past year of screening

Exclusion Criteria:

• known contraindication or hypersensitivities to any components of the investigational product medication or components
• history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
• presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
• presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
• diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
• woman of childbearing potential who is pregnant or nursing

Contacts and Locations

Locations

Canada, Ontario

Cliantha Research

Mississauga, Ontario, Canada

Sponsors and Collaborators

Aldeyra Therapeutics, Inc.

More Information

• Responsible Party: Aldeyra Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04207736
• Other Study ID Numbers: ADX-102-AC-017
• First Posted: December 23, 2019
• Last Update Posted: January 5, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aldeyra Therapeutics, Inc.:

reproxalap; INVIGORATE; ADX-102

Additional relevant MeSH terms:

Conjunctivitis; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pharmaceutical Solutions; Ophthalmic Solutions