Trial Outcomes & Findings for A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis (NCT NCT03660878)

Last Updated: 2025-04-08

Results Overview

Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.

Results posted on

2025-04-08

Participant Flow

Intent-to-treat population

Participant milestones

Participant milestones
Measure	Reproxalap Ophthalmic Solution (0.25%) Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Reproxalap Ophthalmic Solution (0.5%) Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Vehicle Ophthalmic Solution Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks
Overall Study STARTED	18	17	17
Overall Study COMPLETED	17	15	17
Overall Study NOT COMPLETED	1	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reproxalap Ophthalmic Solution (0.25%) n=18 Participants Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Reproxalap Ophthalmic Solution (0.5%) n=17 Participants Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Vehicle Ophthalmic Solution n=17 Participants Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	16 Participants n=4 Participants	16 Participants n=27 Participants	48 Participants n=483 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	11 Participants n=4 Participants	11 Participants n=27 Participants	35 Participants n=483 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	17 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=93 Participants	9 Participants n=4 Participants	11 Participants n=27 Participants	30 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=93 Participants	8 Participants n=4 Participants	6 Participants n=27 Participants	22 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized White	15 Participants n=93 Participants	17 Participants n=4 Participants	16 Participants n=27 Participants	48 Participants n=483 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	18 participants n=93 Participants	17 participants n=4 Participants	17 participants n=27 Participants	52 participants n=483 Participants
Iris Color (Right Eye) Black	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Iris Color (Right Eye) Blue	3 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	8 Participants n=483 Participants
Iris Color (Right Eye) Brown	10 Participants n=93 Participants	10 Participants n=4 Participants	13 Participants n=27 Participants	33 Participants n=483 Participants
Iris Color (Right Eye) Hazel	1 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants
Iris Color (Right Eye) Green	3 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Iris Color (Right Eye) Gray	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Iris Color (Right Eye) Other	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Iris Color (Left Eye) Black	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Iris Color (Left Eye) Blue	3 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	8 Participants n=483 Participants
Iris Color (Left Eye) Brown	10 Participants n=93 Participants	10 Participants n=4 Participants	13 Participants n=27 Participants	33 Participants n=483 Participants
Iris Color (Left Eye) Hazel	1 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants
Iris Color (Left Eye) Green	3 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Iris Color (Left Eye) Gray	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Iris Color (Left Eye) Other	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.

Population: Intent-to-treat population and subjects with pollen count greater than 325 grains per cubic meter.

Outcome measures

Outcome measures
Measure	Reproxalap Ophthalmic Solution (0.25%) n=5 Participants Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Vehicle Ophthalmic Solution n=4 Participants Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Reproxalap Ophthalmic Solution (0.5%) n=5 Participants Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks
Change From Baseline Ocular Itching Score on High Pollen Days	-0.65 units on a scale Standard Error 0.17	0.16 units on a scale Standard Error 0.18	-0.69 units on a scale Standard Error 0.30

Adverse Events

Reproxalap Ophthalmic Solution (0.25%)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Reproxalap Ophthalmic Solution (0.5%)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Vehicle Ophthalmic Solution

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Reproxalap Ophthalmic Solution (0.25%) n=18 participants at risk Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Reproxalap Ophthalmic Solution (0.5%) n=17 participants at risk Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Vehicle Ophthalmic Solution n=17 participants at risk Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks
Nervous system disorders Central nervous system lesion	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.

Other adverse events

Other adverse events
Measure	Reproxalap Ophthalmic Solution (0.25%) n=18 participants at risk Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Reproxalap Ophthalmic Solution (0.5%) n=17 participants at risk Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks	Vehicle Ophthalmic Solution n=17 participants at risk Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks
Investigations Skin test positive	5.6% 1/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Nervous system disorders Headache	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Immune system disorders Hypersensitivity	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Infections and infestations Hordeolum	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Conjunctival disorder	5.6% 1/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Blepharitis	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Dry eye	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Eye discharge	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Eye Swelling	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Punctate keratitis	5.6% 1/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Vitreous detachment	5.6% 1/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Nervous system disorders Vitreous floaters	5.6% 1/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
General disorders Instillation site erythema	0.00% 0/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	5.9% 1/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
General disorders General disorders and administration site conditions	72.2% 13/18 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	94.1% 16/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.

Additional Information

Sr. Director, Clinical Operations

Aldeyra Therapeutics, Inc.

Phone: 781-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place