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History of Changes for Study: NCT04207736
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
Latest version (submitted January 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 20, 2019 None (earliest Version on record)
2 December 20, 2019 Outcome Measures, Study Identification and Study Status
3 November 5, 2020 Study Status
4 February 1, 2021 Study Status
5 July 19, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 January 3, 2022 Study Status
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Study NCT04207736
Submitted Date:  December 20, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: ADX-102-AC-017
Brief Title: 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
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2019
Overall Status: Recruiting
Study Start: December 5, 2019
Primary Completion: September 2020 [Anticipated]
Study Completion: September 2020 [Anticipated]
First Submitted: December 19, 2019
First Submitted that
Met QC Criteria:
December 20, 2019
First Posted: December 23, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
December 20, 2019
Last Update Posted: December 23, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Aldeyra Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
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).
Open or close this module Conditions
Conditions: Allergic Conjunctivitis
Keywords: reproxalap
INVIGORATE
ADX-102
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 126 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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 scale (0-4).
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 scale (0-4).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Bill Cavanagh
Telephone: 781-257-3063
Email: bcavanagh@aldeyra.com
Locations: Canada, Ontario
Cliantha Research
[Recruiting]
Mississauga, Ontario, Canada
Contact:Contact: Peter Couroux, MD 905-282-1808 pcouroux@cliantha.ca
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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