A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis

• ClinicalTrials.gov Identifier: NCT03660878
• Recruitment Status: Completed
• First Posted: September 7, 2018
• Last Update Posted: December 7, 2020
• Sponsor: Aldeyra Therapeutics, Inc.
• Information provided by (Responsible Party): Aldeyra Therapeutics, Inc.

Study Description

Brief Summary:

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.

Condition or disease	Intervention/treatment	Phase
Allergic Conjunctivitis	Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Reproxalap Ophthalmic Solution (0.5%); Drug: Vehicle Ophthalmic Solution	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial With Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis
• Actual Study Start Date: September 8, 2018
• Actual Primary Completion Date: November 19, 2019
• Actual Study Completion Date: November 19, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%)	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.
Experimental: Reproxalap Ophthalmic Solution (0.5%)	Drug: Reproxalap Ophthalmic Solution (0.5%); Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.

Outcome Measures

Primary Outcome Measures :

1. Ocular itching evaluated by the Subject, safety, and tolerability. [ Time Frame: Efficacy assessment period (Day 1 through Day 29) ]
   The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale.

Secondary Outcome Measures :

1. Adverse event assessment. [ Time Frame: Safety assessment period (Day 1 through Day 29) ]
   Collection of adverse events.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
• 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 any of the investigational product medication or 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 months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
• have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
• have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
• be a female who is currently pregnant, planning a pregnancy, or lactating

Contacts and Locations

Locations

United States, Texas

Slade & Baker Vision

Houston, Texas, United States, 77027

Sponsors and Collaborators

Aldeyra Therapeutics, Inc.

More Information

• Responsible Party: Aldeyra Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03660878
• Other Study ID Numbers: ADX-102-AC-010
• First Posted: September 7, 2018
• Last Update Posted: December 7, 2020
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• 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:

Conjunctivitis; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pharmaceutical Solutions; Ophthalmic Solutions