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

The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.: Condition:   Allergic Conjunctivitis Interventions:   Drug: Reproxalap Ophthalmic Solution (0.25%);   Drug: Vehicle Ophthalmic Solution Sponsor:   Aldeyra Therapeutics, Inc. Recruiting (Source: ClinicalTrials.gov)






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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04207736

Recruitment Status  : Recruiting

First Posted  : December 23, 2019

Last Update Posted  : December 23, 2019

See Contacts and Locations

Sponsor:

Aldeyra Therapeutics, Inc.

Information provided by (Responsible Party):

Aldeyra Therapeutics, Inc.



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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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

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Study Type  : Interventional  (Clinical Trial)

Estimated Enrollment  : 126 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

Estimated Primary Completion Date  : September 2020

Estimated Study Completion Date  : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

U.S. FDA Resources



Arms and Interventions

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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

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Primary Outcome Measures  :

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  :

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

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04207736





Contacts

Contact: Bill Cavanagh 781-257-3063 bcavanagh@aldeyra.com



Locations

Canada, Ontario

Cliantha Research Recruiting

Mississauga, Ontario, Canada

Contact: Peter Couroux, MD    905-282-1808    pcouroux@cliantha.ca 

Sponsors and Collaborators

Aldeyra Therapeutics, Inc.

More Information

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Responsible Party: Aldeyra Therapeutics, Inc.

ClinicalTrials.gov Identifier: NCT04207736     History of Changes

Other Study ID Numbers: ADX-102-AC-017

First Posted: December 23, 2019    Key Record Dates

Last Update Posted: December 23, 2019

Last Verified: December 2019

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

Ophthalmic Solutions

Pharmaceutical Solutions





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