The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

Sponsor
Aldeyra Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05234554
Collaborator
(none)
58
1
2
16.2
3.6

Study Details

Study Description

Brief Summary

The INVIGORATE 2 Trial: A single-center, 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Reproxalap Ophthalmic Solution (0.25%)
  • Drug: Vehicle Ophthalmic Solution
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The INVIGORATE 2 Trial: A Single-center, 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 :
Jan 21, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%)

Drug: Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Placebo Comparator: Vehicle Ophthalmic Solution

Drug: Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed twice.

Outcome Measures

Primary Outcome Measures

  1. Ocular itching evaluated by the Subject. [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. [During EEC allergen exposure.]

    The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none - 4 extremely severe).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Be at least 18 years of age at the time of screening of either sex or any race;

  • Provide written informed consent;

  • Be willing and able to follow instructions, and can attend all required clinical trial visits.

  • Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;

  • Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).

Exclusion Criteria:
  • Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;

  • Have systemic signs of infection (e.g., fever, current treatment with antibiotics).

  • Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;

  • Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;

  • Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliantha Research Mississauga Ontario Canada

Sponsors and Collaborators

  • Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05234554
Other Study ID Numbers:
  • ADX-102-AC-026
First Posted:
Feb 10, 2022
Last Update Posted:
May 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022