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Trial record 12 of 200 for:    allergic conjunctivitis

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 24, 2019
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

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).

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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

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.




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).



Information from the National Library of Medicine

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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

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

Locations
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Canada, Ontario
Cliantha Research Recruiting
Mississauga, Ontario, Canada
Contact: Peter Couroux, MD    905-282-1808    pcouroux@cliantha.ca   
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.

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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04207736    
Other Study ID Numbers: ADX-102-AC-017
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019

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