Dry Eye DiseasePhase 3NCT06544707

A Study Designed to Evaluate Tear Production

A Phase 3 study testing 0.003% AR-15512 ophthalmic solution in people with Dry Eye Disease, run by Alcon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Disease
What is being tested?: 0.003% AR-15512 ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteUnited States
Study dates: 15 Oct 2024to 30 Jan 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
Corrected visual acuity score of 20/200 or better in both eyes.
Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.
Other protocol specified inclusion criteria may apply.

Who cannot join

Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
History of ocular surgery within 1 year of the Study Visit.
Use of contact lenses in either eye within 7 days of the Study Visit.
Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.
Used artificial tears within 2 hours of the Study Visit.
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Eye Research Foundation
Newport Beach, California, 92663

Other trials in United States

About this study

Official title: A Phase 3b Open-Label Study Designed to Evaluate Tear Production Stimulated by 0.003% AR-15512

The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED).

Read the detailed description

Qualified subjects will attend a single visit.

This is a Phase 3b, 2-stage study. In Stage 1, approximately 40 subjects will be enrolled, after which the study will be paused and an interim analysis will be conducted. Results from the Stage 1 analysis will help inform the design of Stage 2. An additional 40 subjects are planned for Stage 2.

For both stages, the primary endpoint and analysis will remain the same. Stage 2 will be tested independently with no pooling of data between stages.

Conditions: Dry Eye Disease
Being tested: 0.003% AR-15512 ophthalmic solution
Keywords: Dry Eyes, Eye Drops
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.003% AR-15512 ophthalmic solutionDrug
Also called TRYPTYR®, Acoltremon ophthalmic solution 0.003%
Investigational ophthalmic solution administered via topical instillation

Study groups in NCT06544707
Study group	Role	What they receive
0.003% AR-15512	Experimental	One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours) Receives: Drug: 0.003% AR-15512 ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
Measured: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation
Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 2
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
Measured: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202430 Jan 2025

First posted9 Aug 2024
Study start15 Oct 2024
Primary completion30 Jan 2025
Study completion30 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06544707
Sponsor's protocol ID: DEF512-E002
Status last verified: Jan 2026
First submitted: 6 Aug 2024
Last updated: 10 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b Open-Label Study Designed to Evaluate Tear Production Stimulated by 0.003% AR-15512
ClinicalTrials.gov ID: NCT06544707
Acronym / sponsor ID: DEF512-E002
Conditions: Dry Eye Disease
Keywords: Dry Eyes, Eye Drops
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 15 Oct 2024 (actual)
Primary completion: 30 Jan 2025 (actual)
Study completion: 30 Jan 2025 (actual)
First posted: 9 Aug 2024 (actual)
Results: Posted 10 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED).

Detailed description

Qualified subjects will attend a single visit.

For both stages, the primary endpoint and analysis will remain the same. Stage 2 will be tested independently with no pooling of data between stages.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
0.003% AR-15512	Experimental	Drug: 0.003% AR-15512 ophthalmic solutionOne drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
Corrected visual acuity score of 20/200 or better in both eyes.
Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.
Other protocol specified inclusion criteria may apply.

Key exclusion criteria (7 listed)

Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
History of ocular surgery within 1 year of the Study Visit.
Use of contact lenses in either eye within 7 days of the Study Visit.
Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.003% AR-15512 ophthalmic solutionAlso: TRYPTYR®, Acoltremon ophthalmic solution 0.003%Investigational ophthalmic solution administered via topical instillation	Drug	0.003% AR-15512

Primary outcome

Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1
Time frame: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 2
Time frame: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.

Results and safety

Results posted to the registry on 10 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.003% AR-15512 - Stage 1	40	40
0.003% AR-15512 - Stage 2	41	41

Primary outcome: Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1

Time frame: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation. Mean (Standard Deviation). Unit: micrometers

Measure	0.003% AR-15512 - Stage 1 n = 40
Value	519.65 (515.561)

0.003% AR-15512 - Stage 1: p <0.0001, t-test, 1 sided

Population analysed: Full Analysis Set

Primary outcome: Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 2

Time frame: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation. Mean (Standard Deviation). Unit: micrometers

Measure	0.003% AR-15512 - Stage 2 n = 41
Value	503.80 (559.552)

0.003% AR-15512 - Stage 2: p <0.0001, t-test, 1 sided

Population analysed: Full Analysis Set

Adverse events

Time frame: Adverse Events (AEs) were collected from time of consent until study exit, approximately 1 day.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 81 (0%)	0 of 81 (0%)	0 of 81
0.003% AR-15512 - Stage 1	0 of 40 (0%)	19 of 40 (47.5%)	0 of 40
0.003% AR-15512 - Stage 2	0 of 41 (0%)	16 of 41 (39%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Lead, Pharma study director

Alcon Research, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 0.003% AR-15512 ophthalmic solution in people with Dry Eye Disease, run by Alcon Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1 (time frame: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06544707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.