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

Allergic Conjunctivitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207736
• Other study ID #: ADX-102-AC-017
• Status: Completed
• Phase: Phase 3
• Start date: December 5, 2019
• Est. completion date: February 16, 2021

Study information

• Verified date: January 2022
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 16, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.
• Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.

Locations

Country	Name	City	State
Canada	Cliantha Research	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Conjunctival Redness evaluated by the Subject.	The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none -4 extremely sever).	During EEC allergen exposure.