CompletedNCT03162783Updated Jan 16, 2025Results posted

A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome

A Phase 2 interventional study of ADX-102 Ophthalmic Solution (0.5%) and ADX-102 Ophthalmic Solution (0.1%) in Dry Eye Syndromes, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-16.

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

Phase: Phase 2
Study type: Interventional
Enrollment: 51
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome.

Conditions studied

Dry Eye Syndromes

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Keywords

Aldeyra

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.

This study's enrollment of 51 is below 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 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 reported history of dry eye for at least 6 months prior to Visit 1;
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

Exclusion criteria

Exclusion Criteria:

Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used cyclosporine 0.05% or lifitegrast 5.0% ophthalmic solution within 45 days of Visit 1;
Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months;
Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

Study design

Phase: Phase 2
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 51 participants (actual)

Study arms

Experimental
ADX-102 Ophthalmic Solution (0.5%)
Drug: ADX-102 Ophthalmic Solution (0.5%)
Experimental
ADX-102 Ophthalmic Solution (0.1%)
Drug: ADX-102 Ophthalmic Solution (0.1%)
Experimental
ADX-102 Ophthalmic Lipid Solution (0.5%)
Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)

Interventions

DrugADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.
DrugADX-102 Ophthalmic Solution (0.1%)
ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
DrugADX-102 Ophthalmic Lipid Solution (0.5%)
ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.

What researchers measure

Primary outcomes

Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Time frame: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.

Results

Posted Jan 16, 2025

Participant flow

Participant flow — Overall Study
Milestone	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Lipid Solution (0.5%)
Started	17	17	17
Completed	12	16	11
Not completed	5	1	6

Outcome measures

PrimaryEfficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.

Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Time frame:: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.
Reported as:: Mean · units on a scale

Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
units on a scale	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Lipid Solution (0.5%)
Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.	-0.81 ± 0.98	-0.75 ± 0.75	-0.82 ± 1.33

Adverse events

Collected over The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ADX-102 Ophthalmic Solution (0.5%)	0/17 (0%)	0/17 (0%)	17/17 (100%)
ADX-102 Ophthalmic Solution (0.1%)	0/17 (0%)	0/17 (0%)	8/17 (47.1%)
ADX-102 Ophthalmic Lipid Solution (0.5%)	0/17 (0%)	0/17 (0%)	17/17 (100%)

Most frequent other events

Most frequent other events
Event	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Lipid Solution (0.5%)
Instillation site irritationGeneral disorders	17/17	8/17	16/17
Instillation site discomfortGeneral disorders	0/17	0/17	1/17
Vision blurredEye disorders	1/17	0/17	1/17
Eyelid margin crustingEye disorders	0/17	0/17	1/17
Ocular discomfortEye disorders	0/17	0/17	1/17
DiarrheaGastrointestinal disorders	1/17	0/17	0/17
EpistaxisRespiratory, thoracic and mediastinal disorders	0/17	1/17	0/17

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Lipid Solution (0.5%)	Total
<=18 years	0	0	0	0
Between 18 and 65 years	7	7	4	18
>=65 years	10	10	13	33

Sex: Female, Male
Sex: Female, Male(Participants)	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Lipid Solution (0.5%)	Total
Female	14	9	11	34
Male	3	8	6	17

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Lipid Solution (0.5%)	Total
Hispanic or Latino	2	0	0	2
Not Hispanic or Latino	15	17	17	49
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Lipid Solution (0.5%)	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	2	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	1	0	0	1
White	16	15	17	48
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Iris Color (Right Eye)
Iris Color (Right Eye)(participants)	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Lipid Solution (0.5%)	Total
Black	0	0	0	0
Blue	7	2	5	14
Brown	6	13	6	25
Hazel	3	1	4	8
Green	1	1	2	4
Gray	0	0	0	0
Other	0	0	0	0

Iris Color (Left Eye)
Iris Color (Left Eye)(participants)	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Lipid Solution (0.5%)	Total
Black	0	0	0	0
Blue	7	2	5	14
Brown	6	13	6	25
Hazel	3	1	4	8
Green	1	1	2	4
Gray	0	0	0	0
Other	0	0	0	0

Study locations

1 site

Andover Eye Associates
Andover, Massachusetts 01810, United States

References and documents

Publications

Clark D, Sheppard J, Brady TC. A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease. J Ocul Pharmacol Ther. 2021 May;37(4):193-199. doi: 10.1089/jop.2020.0087. Epub 2021 Jan 15. PubMed 33450164 ↗

Study documents

Study protocol · Mar 27, 2017
Statistical analysis plan · Jun 2, 2017

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 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03162783
Lead sponsor: Aldeyra Therapeutics, Inc.
Responsible party: Sponsor
First posted: May 22, 2017
Start date: May 15, 2017
Primary completion: Jul 6, 2017
Completion: Jul 6, 2017
Results posted: Jan 16, 2025
Last update: Jan 16, 2025

Oversight

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

View the source record on ClinicalTrials.gov ↗

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

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