CompletedNCT05424549Updated Jan 15, 2025Results posted

A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

A Phase 2 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Vehicle Ophthalmic Solution in Dry Eye Syndromes, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by Aldeyra Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 3 months after the study started (first participant enrolled Mar 2022, registered Jun 2022).

Phase: Phase 2
Study type: Interventional
Enrollment: 63
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Conditions studied

Dry Eye Syndromes

Browse trials for

Keywords

dry eye disease
reproxalap
Aldeyra
ADX-102

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 63 is close to the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Aldeyra Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 22 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Eighteen (18) to 70 years of age at the time of screening (either gender and any race)
Ability to provide written informed consent
Reported history of dry eye for at least 6 months prior to screening
Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening

Exclusion criteria

Exclusion Criteria:

Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening
Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
Women of childbearing potential (WOCBP) who are pregnant and nursing
If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
Known allergy and/or sensitivity to reproxalap or the drug product vehicle
A condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial
Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 63 participants (actual)

Study arms

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

Interventions

DrugReproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days
DrugVehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed six times over two consecutive days

What researchers measure

Primary outcomes

Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber
Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.
Time frame: The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.
Schirmer Test Mean Change From Baseline
Change from baseline comparison of reproxalap to vehicle for schirmer test on a millimeter line (0 = none, 35 = maximum). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.
Time frame: The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period.

Results

Posted Jan 15, 2025

Participant flow

Participant flow — Overall Study
Milestone	Reproxalap (0.25%) First, Then Vehicle	Vehicle First, Then Reproxalap (0.25%)
Started	32	31
Completed	29	28
Not completed	3	3

Outcome measures

PrimaryConjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber

Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.

Time frame:: The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.
Reported as:: Least squares mean · score on a scale

Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber
score on a scale	Reproxalap (0.25%)	Vehicle
Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber	0.33 (0.23 to 0.43)	0.44 (0.34 to 0.54)

PrimarySchirmer Test Mean Change From Baseline

Change from baseline comparison of reproxalap to vehicle for schirmer test on a millimeter line (0 = none, 35 = maximum). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.

Time frame:: The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period.
Reported as:: Least squares mean · score on a scale

Schirmer Test Mean Change From Baseline
score on a scale	Reproxalap (0.25%)	Vehicle
Schirmer Test Mean Change From Baseline	-0.06 (-1.82 to 1.70)	-2.54 (-4.22 to -0.86)

Adverse events

Collected over Two days for each intervention. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Reproxalap (0.25%)	0/61 (0%)	0/61 (0%)	56/61 (91.8%)
Vehicle	0/60 (0%)	0/60 (0%)	2/60 (3.3%)

Most frequent other events

Most frequent other events
Event	Reproxalap (0.25%)	Vehicle
General disorders and administration site conditionsGeneral disorders	56/61	2/60

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Reproxalap (0.25%) First, Then Vehicle	Vehicle First, Then Reproxalap (0.25%)	Total
<=18 years	0	0	0
Between 18 and 65 years	30	29	59
>=65 years	2	2	4

Age, Continuous
Age, Continuous(years)	Reproxalap (0.25%) First, Then Vehicle	Vehicle First, Then Reproxalap (0.25%)	Total
Mean	47.0 ± 13.12	51.2 ± 12.14	49.1 ± 12.72

Sex: Female, Male
Sex: Female, Male(Participants)	Reproxalap (0.25%) First, Then Vehicle	Vehicle First, Then Reproxalap (0.25%)	Total
Female	17	24	41
Male	15	7	22

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Reproxalap (0.25%) First, Then Vehicle	Vehicle First, Then Reproxalap (0.25%)	Total
American Indian or Alaska Native	0	0	0
Asian	6	6	12
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	1	3
White	24	19	43
More than one race	0	5	5
Unknown or Not Reported	0	0	0

Intraocular Pressure (right eye)
Intraocular Pressure (right eye)(mmHg)	Reproxalap (0.25%) First, Then Vehicle	Vehicle First, Then Reproxalap (0.25%)	Total
Mean	11.6 ± 2.08	12.0 ± 2.76	11.8 ± 2.42

Intraocular Pressure (left eye)
Intraocular Pressure (left eye)(mmHg)	Reproxalap (0.25%) First, Then Vehicle	Vehicle First, Then Reproxalap (0.25%)	Total
Mean	11.7 ± 1.97	11.6 ± 2.61	11.6 ± 2.29

Study locations

1 site

Cliantha Research
Mississauga, Ontario L4W 1A4, Canada

References and documents

Study documents

Study protocol · Jun 13, 2022
Statistical analysis plan · Jun 14, 2022

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

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05424549
Lead sponsor: Aldeyra Therapeutics, Inc.
Responsible party: Sponsor
First posted: Jun 21, 2022
Start date: Mar 9, 2022
Primary completion: May 9, 2022
Completion: May 9, 2022
Results posted: Jan 15, 2025
Last update: Jan 15, 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 Jun 2022. 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

Dry Eye Syndromes→

Other studies from this sponsor

Aldeyra Therapeutics, Inc.

Start the discussion