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

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

Tracking Information
First Submitted Date  ICMJE December 19, 2019
First Posted Date  ICMJE December 23, 2019
Last Update Posted Date January 5, 2022
Actual Study Start Date  ICMJE December 5, 2019
Actual Primary Completion Date February 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
Ocular itching evaluated by the Subject. [ Time Frame: During EEC allergen exposure. ]
The method of assessment for the primary outcome is a 9-point scale (0-4).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
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 scale (0-4).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE
  • Drug: Reproxalap Ophthalmic Solution (0.25%)
    Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.
  • Drug: Vehicle Ophthalmic Solution
    Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.
Study Arms  ICMJE
  • Active Comparator: Reproxalap Ophthalmic Solution (0.25%)
    Intervention: Drug: Reproxalap Ophthalmic Solution (0.25%)
  • Placebo Comparator: Vehicle Ophthalmic Solution
    Intervention: Drug: Vehicle Ophthalmic Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2021)
95
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2019)
126
Actual Study Completion Date  ICMJE February 16, 2021
Actual Primary Completion Date February 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04207736
Other Study ID Numbers  ICMJE ADX-102-AC-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Aldeyra Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aldeyra Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aldeyra Therapeutics, Inc.
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP