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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03660878
Enrollment
52
Registered
2018-09-07
Start date
2018-09-08
Completion date
2019-11-19
Last updated
2025-04-08

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

Conditions

Allergic Conjunctivitis

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.

Interventions

DRUGReproxalap 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.

DRUGReproxalap 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.

DRUGVehicle Ophthalmic Solution

Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.

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 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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Ocular Itching Score on High Pollen DaysEfficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.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.

Countries

United States

Participant flow

Pre-assignment details

Intent-to-treat population

Participants by arm

ArmCount
Reproxalap Ophthalmic Solution (0.25%)
Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks
18
Reproxalap Ophthalmic Solution (0.5%)
Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks
17
Vehicle Ophthalmic Solution
Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks
17
Total52

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
2 Participants4 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
16 Participants48 Participants16 Participants16 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants30 Participants11 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants22 Participants6 Participants8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Iris Color (Left Eye)
Black
1 Participants2 Participants1 Participants0 Participants
Iris Color (Left Eye)
Blue
3 Participants8 Participants2 Participants3 Participants
Iris Color (Left Eye)
Brown
10 Participants33 Participants13 Participants10 Participants
Iris Color (Left Eye)
Gray
0 Participants0 Participants0 Participants0 Participants
Iris Color (Left Eye)
Green
3 Participants5 Participants0 Participants2 Participants
Iris Color (Left Eye)
Hazel
1 Participants4 Participants1 Participants2 Participants
Iris Color (Left Eye)
Other
0 Participants0 Participants0 Participants0 Participants
Iris Color (Right Eye)
Black
1 Participants2 Participants1 Participants0 Participants
Iris Color (Right Eye)
Blue
3 Participants8 Participants2 Participants3 Participants
Iris Color (Right Eye)
Brown
10 Participants33 Participants13 Participants10 Participants
Iris Color (Right Eye)
Gray
0 Participants0 Participants0 Participants0 Participants
Iris Color (Right Eye)
Green
3 Participants5 Participants0 Participants2 Participants
Iris Color (Right Eye)
Hazel
1 Participants4 Participants1 Participants2 Participants
Iris Color (Right Eye)
Other
0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
1 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black or African American
1 Participants2 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Multiple
0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Other
1 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Unknown
0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
White
15 Participants48 Participants16 Participants17 Participants
Region of Enrollment
United States
18 participants52 participants17 participants17 participants
Sex: Female, Male
Female
13 Participants35 Participants11 Participants11 Participants
Sex: Female, Male
Male
5 Participants17 Participants6 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 170 / 17
other
Total, other adverse events
14 / 1816 / 173 / 17
serious
Total, serious adverse events
0 / 181 / 170 / 17

Outcome results

Primary

Change From Baseline Ocular Itching Score on High Pollen Days

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Reproxalap Ophthalmic Solution (0.25%)Change From Baseline Ocular Itching Score on High Pollen Days-0.65 units on a scaleStandard Error 0.17
Vehicle Ophthalmic SolutionChange From Baseline Ocular Itching Score on High Pollen Days0.16 units on a scaleStandard Error 0.18
Reproxalap Ophthalmic Solution (0.5%)Change From Baseline Ocular Itching Score on High Pollen Days-0.69 units on a scaleStandard Error 0.3

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