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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03660878

Collaborator

(none)

Enrollment

Location

Arms

14.4

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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

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 :

Sep 8, 2018

Actual Primary Completion Date :

Nov 19, 2019

Actual Study Completion Date :

Nov 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.

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

Ocular itching evaluated by the Subject, safety, and tolerability. [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Slade & Baker Vision	Houston	Texas	United States	77027

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:

NCT03660878

Other Study ID Numbers:

ADX-102-AC-010

First Posted:

Sep 7, 2018

Last Update Posted:

Dec 7, 2020

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Conjunctivitis

Conjunctivitis, Allergic

Pharmaceutical Solutions

Ophthalmic Solutions

Study Results

No Results Posted as of Dec 7, 2020