CompletedNCT03494504Updated Feb 11, 2025Results posted

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

A Phase 3 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Reproxalap Ophthalmic Solution (0.5%) in Allergic Conjunctivitis, sponsored by Aldeyra Therapeutics, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Aldeyra Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 318
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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

Conditions studied

Allergic Conjunctivitis

Browse trials for

Keywords

reproxalap

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 318 participants (actual)

Study arms

Experimental
Reproxalap Ophthalmic Solution (0.25%)
Drug: Reproxalap Ophthalmic Solution (0.25%)
Experimental
Reproxalap Ophthalmic Solution (0.5%)
Drug: Reproxalap Ophthalmic Solution (0.5%)
Placebo comparator
Vehicle Ophthalmic Solution
Drug: Vehicle Ophthalmic Solution

Interventions

DrugReproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered once.
DrugReproxalap Ophthalmic Solution (0.5%)
Reproxalap Ophthalmic Solution (0.5%) administered once.
DrugVehicle Ophthalmic Solution
Vehicle Ophthalmic Solution administered once.

What researchers measure

Primary outcomes

Subject-reported Ocular Itching Score
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
Time frame: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.

Secondary outcomes

Number of Subjects With Two-point Reduction in Itching Score
The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed.
Time frame: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.

Results

Posted Feb 11, 2025

Participant flow

Participant flow — Overall Study
Milestone	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution
Started	109	100	109
Completed	109	100	109
Not completed	0	0	0

Outcome measures

PrimarySubject-reported Ocular Itching Score

Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.

Time frame:: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Reported as:: Least squares mean · units on a scale*minutes

Subject-reported Ocular Itching Score
units on a scale*minutes	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution
Subject-reported Ocular Itching Score	52.003 ± 3.3053	60.040 ± 3.4552	74.657 ± 3.3076

SecondaryNumber of Subjects With Two-point Reduction in Itching Score

The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed.

Time frame:: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Reported as:: Count of participants · Participants

Number of Subjects With Two-point Reduction in Itching Score
Participants	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution
Number of Subjects With Two-point Reduction in Itching Score	88	77	77

Statistical analysis

Reproxalap Ophthalmic Solution (0.25%) · Odds ratio (or): 2.36 · 95% CI 1.46 to 3.84
Reproxalap Ophthalmic Solution (0.5%) · Odds ratio (or): 1.81 · 95% CI 1.11 to 2.94

Adverse events

Collected over The period of time over which adverse events were collected for each subject in the clinical trial was approximately two months.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Reproxalap Ophthalmic Solution (0.25%)	0/109 (0%)	0/109 (0%)	31/109 (28.4%)
Reproxalap Ophthalmic Solution (0.5%)	0/100 (0%)	0/100 (0%)	41/100 (41%)
Vehicle Ophthalmic Solution	0/109 (0%)	0/109 (0%)	1/109 (0.9%)

Most frequent other events

Most frequent other events
Event	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution
General disorders and administration site conditionsGeneral disorders	31/109	41/100	1/109

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution	Total
<=18 years	0	0	0	0
Between 18 and 65 years	90	90	102	282
>=65 years	19	10	7	36

Sex: Female, Male
Sex: Female, Male(Participants)	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution	Total
Female	72	62	63	197
Male	37	38	46	121

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution	Total
Hispanic or Latino	19	18	9	46
Not Hispanic or Latino	90	82	100	272
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution	Total
American Indian or Alaska Native	0	0	0	0
Asian	11	9	15	35
Native Hawaiian or Other Pacific Islander	0	0	1	1
Black or African American	11	19	17	47
White	85	71	76	232
More than one race	2	1	0	3
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution	Total
United States	109	100	109	318

Iris Color (Right Eye)
Iris Color (Right Eye)(Participants)	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution	Total
Black	1	2	0	3
Blue	26	25	27	78
Brown	57	52	64	173
Hazel	13	9	10	32
Green	10	11	8	29
Gray	2	1	0	3
Other	0	0	0	0

Iris Color (Left Eye)
Iris Color (Left Eye)(Participants)	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution	Total
Black	1	2	0	3
Blue	26	25	27	78
Brown	57	52	64	173
Hazel	13	9	10	32
Green	10	11	8	29
Gray	2	1	0	3
Other	0	0	0	0

Randomization Stratum
Randomization Stratum(Participants)	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.5%)	Vehicle Ophthalmic Solution	Total
<= 2.7 Average Baseline Itching Score	41	38	42	121
> 2.7 and <= 3.5 Average Baseline Itching Score	31	30	28	89
> 3.5 Average Baseline Itching Score	37	32	39	108

Study locations

7 sites

Cornea Consultants of Arizon
Phoenix, Arizona 85032, United States
Eye Site Sacramento
Sacramento, California 95819, United States
East West Eye Institute
Torrance, California 90505, United States
Seidenberg Protzko Eye Associates
Havre De Grace, Maryland 21078, United States
Andover Eye Associates
Andover, Massachusetts 01810, United States
Eye Clinics of South Texas
San Antonio, Texas 78209, United States
R & R Research, LLC
San Antonio, Texas 78229, United States

References and documents

Study documents

Study protocol · Feb 15, 2018
Statistical analysis plan · Feb 20, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03494504
Lead sponsor: Aldeyra Therapeutics, Inc.
Responsible party: Sponsor
First posted: Apr 11, 2018
Start date: Mar 30, 2018
Primary completion: Nov 5, 2018
Completion: Nov 5, 2018
Results posted: Feb 11, 2025
Last update: Feb 11, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Conjunctivitis→

Other studies from this sponsor

Aldeyra Therapeutics, Inc.

Start the discussion