Dry Eye DiseasePhase 3NCT06544694
A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease
A Phase 3 study testing 0.003% AR-15512 ophthalmic solution and Artificial Tears in people with Dry Eye Disease, run by Alcon Research at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of 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 and Artificial Tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Oct 2024to 21 Mar 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
- Have a previous history of DED, clinician diagnosed or patient reported, within the previous 6 months prior to the Screening visit.
- Have used artificial tears for DED symptoms within 2 months prior to the Screening visit.
- Corrected visual acuity equal to or better than logarithm Minimum angle of reflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at both the Screening and Baseline visits.
- 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
- History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety.
- Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation.
- History of ocular surgery within 1 year prior to the Screening visit; history of corneal transplant in one or both eyes.
- Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study.
- Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the Screening visit or any planned use during the study.
- Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Oculus Research
Garner, North Carolina, 27529
Wilmington Eye
Leland, North Carolina, 28451
Butchertown Clinical Trials
Louisville, Kentucky, 40206
CORE, Inc.
Shelby, North Carolina, 28150
About this study
Official title: A Phase 3b Study to Investigate the Effect of 0.003% AR-15512 on the Ocular Surface Characteristics of Subjects With Dry Eye Disease
The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).
Read the detailed description
Qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. During the run-in period, subjects will administer Artificial Tears (REFRESH® Classic) as one drop in each eye twice daily.
This is a Phase 3b study.
- Conditions
- Dry Eye Disease
- Being tested
- 0.003% AR-15512 ophthalmic solution, Artificial Tears
- 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
Artificial TearsOther
Also called REFRESH® Classic
Commercially available, preservative-free lubricant eye drops administered via topical instillation
| Study group | Role | What they receive |
|---|---|---|
| 0.003% AR-15512 | Experimental | One drop of 0.003% AR-15512 ophthalmic solution in each eye twice daily for 90 days (treatment period) Receives: Drug: 0.003% AR-15512 ophthalmic solution |
| Artificial Tears | Active comparator | One drop of artificial tears in each eye twice daily for 90 days (treatment period) Receives: Other: Artificial Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512
Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva were collected on filter papers based on a technique called impression cytology. The filter papers were then processed in a lab to measure the number of goblet cells (cells/mm2). The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) was calculated. A positive change value indicates an improvement. Only one eye (study eye) contributed data to the analysis. This outcome measure was pre-specified for 0.003% AR-15512 arm only.
Measured: Day 1 pre-instillation (Baseline), Day 90 post instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start8 Oct 2024
- Primary completion21 Mar 2025
- Study completion21 Mar 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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Pharma, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544694
- Sponsor's protocol ID
- DEF512-E003
- Status last verified
- Mar 2026
- First submitted
- 6 Aug 2024
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Study to Investigate the Effect of 0.003% AR-15512 on the Ocular Surface Characteristics of Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06544694
- Acronym / sponsor ID
- DEF512-E003
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eyes, Eye Drops
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Posted 27 Mar 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 the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).
Detailed description
Qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. During the run-in period, subjects will administer Artificial Tears (REFRESH® Classic) as one drop in each eye twice daily.
This is a Phase 3b study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| 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 twice daily for 90 days (treatment period) |
| Artificial Tears | Active comparator | Other: Artificial TearsOne drop of artificial tears in each eye twice daily for 90 days (treatment period) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a previous history of DED, clinician diagnosed or patient reported, within the previous 6 months prior to the Screening visit.
- Have used artificial tears for DED symptoms within 2 months prior to the Screening visit.
- Corrected visual acuity equal to or better than logarithm Minimum angle of reflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at both the Screening and Baseline visits.
- 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)
- History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety.
- Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation.
- History of ocular surgery within 1 year prior to the Screening visit; history of corneal transplant in one or both eyes.
- Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study.
- Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the Screening visit or any planned use during the study.
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 |
| Artificial TearsAlso: REFRESH® ClassicCommercially available, preservative-free lubricant eye drops administered via topical instillation | Other | Artificial Tears |
Primary outcome
Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512
Time frame: Day 1 pre-instillation (Baseline), Day 90 post instillation
Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva were collected on filter papers based on a technique called impression cytology. The filter papers were then processed in a lab to measure the number of goblet cells (cells/mm2). The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) was calculated. A positive change value indicates an improvement. Only one eye (study eye) contributed data to the analysis. This outcome measure was pre-specified for 0.003% AR-15512 arm only.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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
4 sites 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 and Artificial Tears in people with Dry Eye Disease, run by Alcon Research at 4 sites 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 27 Mar 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?
Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512 (time frame: Day 1 pre-instillation (Baseline), Day 90 post instillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.