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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04207736

Collaborator

(none)

Enrollment

Location

Arms

14.4

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Actual Study Start Date :

Dec 5, 2019

Actual Primary Completion Date :

Feb 16, 2021

Actual Study Completion Date :

Feb 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.

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

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

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 sever).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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