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

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring reproxalap, INVIGORATE, ADX-102

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cliantha Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution

Arm Description

Outcomes

Primary Outcome Measures

Ocular itching evaluated by the Subject.
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.
The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none -4 extremely sever).

Full Information

First Posted
December 19, 2019
Last Updated
January 3, 2022
Sponsor
Aldeyra Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04207736
Brief Title
The INVIGORATE Trial: A 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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
February 16, 2021 (Actual)
Study Completion Date
February 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
reproxalap, INVIGORATE, ADX-102

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reproxalap Ophthalmic Solution (0.25%)
Arm Type
Active Comparator
Arm Title
Vehicle Ophthalmic Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.25%)
Intervention Description
Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution
Intervention Description
Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.
Primary Outcome Measure Information:
Title
Ocular itching evaluated by the Subject.
Description
The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe).
Time Frame
During EEC allergen exposure.
Secondary Outcome Measure Information:
Title
Conjunctival Redness evaluated by the Subject.
Description
The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none -4 extremely sever).
Time Frame
During EEC allergen exposure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cliantha Research
City
Mississauga
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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