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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03494504
Enrollment
318
Registered
2018-04-11
Start date
2018-03-30
Completion date
2018-11-05
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Keywords

reproxalap

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

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.

Sponsors

Aldeyra Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Subject-reported Ocular Itching ScoreEfficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.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.

Secondary

MeasureTime frameDescription
Number of Subjects With Two-point Reduction in Itching ScoreEfficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Reproxalap Ophthalmic Solution (0.25%)
Reproxalap administered once 10 minutes prior to pollen exposure
109
Reproxalap Ophthalmic Solution (0.5%)
Reproxalap administered once 10 minutes prior to pollen exposure
100
Vehicle Ophthalmic Solution
Vehicle administered once 10 minutes prior to pollen exposure
109
Total318

Baseline characteristics

CharacteristicReproxalap Ophthalmic Solution (0.25%)TotalVehicle Ophthalmic SolutionReproxalap Ophthalmic Solution (0.5%)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
19 Participants36 Participants7 Participants10 Participants
Age, Categorical
Between 18 and 65 years
90 Participants282 Participants102 Participants90 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants46 Participants9 Participants18 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
90 Participants272 Participants100 Participants82 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Iris Color (Left Eye)
Black
1 Participants3 Participants0 Participants2 Participants
Iris Color (Left Eye)
Blue
26 Participants78 Participants27 Participants25 Participants
Iris Color (Left Eye)
Brown
57 Participants173 Participants64 Participants52 Participants
Iris Color (Left Eye)
Gray
2 Participants3 Participants0 Participants1 Participants
Iris Color (Left Eye)
Green
10 Participants29 Participants8 Participants11 Participants
Iris Color (Left Eye)
Hazel
13 Participants32 Participants10 Participants9 Participants
Iris Color (Left Eye)
Other
0 Participants0 Participants0 Participants0 Participants
Iris Color (Right Eye)
Black
1 Participants3 Participants0 Participants2 Participants
Iris Color (Right Eye)
Blue
26 Participants78 Participants27 Participants25 Participants
Iris Color (Right Eye)
Brown
57 Participants173 Participants64 Participants52 Participants
Iris Color (Right Eye)
Gray
2 Participants3 Participants0 Participants1 Participants
Iris Color (Right Eye)
Green
10 Participants29 Participants8 Participants11 Participants
Iris Color (Right Eye)
Hazel
13 Participants32 Participants10 Participants9 Participants
Iris Color (Right Eye)
Other
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
11 Participants35 Participants15 Participants9 Participants
Race (NIH/OMB)
Black or African American
11 Participants47 Participants17 Participants19 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
85 Participants232 Participants76 Participants71 Participants
Randomization Stratum
> 2.7 and <= 3.5 Average Baseline Itching Score
31 Participants89 Participants28 Participants30 Participants
Randomization Stratum
<= 2.7 Average Baseline Itching Score
41 Participants121 Participants42 Participants38 Participants
Randomization Stratum
> 3.5 Average Baseline Itching Score
37 Participants108 Participants39 Participants32 Participants
Region of Enrollment
United States
109 Participants318 Participants109 Participants100 Participants
Sex: Female, Male
Female
72 Participants197 Participants63 Participants62 Participants
Sex: Female, Male
Male
37 Participants121 Participants46 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1090 / 1000 / 109
other
Total, other adverse events
31 / 10941 / 1001 / 109
serious
Total, serious adverse events
0 / 1090 / 1000 / 109

Outcome results

Primary

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.

Population: Intent-to-treat population with observed data only

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Reproxalap Ophthalmic Solution (0.25%)Subject-reported Ocular Itching Score52.003 units on a scale*minutesStandard Error 3.3053
Reproxalap Ophthalmic Solution (0.5%)Subject-reported Ocular Itching Score60.040 units on a scale*minutesStandard Error 3.4552
Vehicle Ophthalmic SolutionSubject-reported Ocular Itching Score74.657 units on a scale*minutesStandard Error 3.3076
Secondary

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.

Population: Intent-to-treat population with observed data only

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Reproxalap Ophthalmic Solution (0.25%)Number of Subjects With Two-point Reduction in Itching Score88 Participants
Reproxalap Ophthalmic Solution (0.5%)Number of Subjects With Two-point Reduction in Itching Score77 Participants
Vehicle Ophthalmic SolutionNumber of Subjects With Two-point Reduction in Itching Score77 Participants
95% CI: [1.46, 3.84]
95% CI: [1.11, 2.94]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026