ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

• ClinicalTrials.gov Identifier: NCT03494504
• Recruitment Status: Completed
• First Posted: April 11, 2018
• Last Update Posted: November 6, 2019
• Sponsor: Aldeyra Therapeutics, Inc.
• Information provided by (Responsible Party): Aldeyra Therapeutics, Inc.

Tracking Information

• First Submitted Date: April 4, 2018
• First Posted Date: April 11, 2018
• Last Update Posted Date: November 6, 2019
• Actual Study Start Date: March 30, 2018
• Actual Primary Completion Date: November 5, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2018)

Ocular itching evaluated by the Subject. [ Time Frame: Efficacy assessment period (Day -21 through Day 1) ]

The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03494504 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: April 4, 2018)

Conjunctival redness [ Time Frame: Efficacy assessment period (Day -21 through Day 1) ]

The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
• Official Title: A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis
• Brief Summary: A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Allergic Conjunctivitis

Intervention

• Drug: Reproxalap Ophthalmic Solution (0.25%)
  Reproxalap Ophthalmic Solution (0.25%) administered once.
• Drug: Reproxalap Ophthalmic Solution (0.5%)
  Reproxalap Ophthalmic Solution (0.5%) administered once.
• Drug: Vehicle Ophthalmic Solution
  Vehicle Ophthalmic Solution administered once.

Study Arms

• Experimental: Reproxalap Ophthalmic Solution (0.25%)
  Intervention: Drug: Reproxalap Ophthalmic Solution (0.25%)
• Experimental: Reproxalap Ophthalmic Solution (0.5%)
  Intervention: Drug: Reproxalap Ophthalmic Solution (0.5%)
• Placebo Comparator: Vehicle Ophthalmic Solution
  Intervention: Drug: Vehicle Ophthalmic Solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 8, 2019): 318
• Original Estimated Enrollment (submitted: April 4, 2018): 300
• Actual Study Completion Date: November 5, 2018
• Actual Primary Completion Date: November 5, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• be at least 18 years of age of either gender and any race
• have a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
• have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

Exclusion Criteria:

• have known contraindications or sensitivities to the use of the investigational product or any of its components
• have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
• have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
• have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
• have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
• be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03494504
• Other Study ID Numbers: ADX-102-AC-008
• 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

• Plan to Share IPD: No

• Responsible Party: Aldeyra Therapeutics, Inc.
• Study Sponsor: Aldeyra Therapeutics, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Aldeyra Therapeutics, Inc.
• Verification Date: April 2018