Dry Eye DiseasePhase 3NCT06660290
A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
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 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic). 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
- 55 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jan 2025to 6 Feb 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
- Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
- Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
- Capable of giving signed informed consent.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Current evidence of other clinically significant ophthalmic disease other than dry eye;
- History of ocular surgery within 1 year of the Study Visit;
- Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
- Positive pregnancy test or currently breastfeeding.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Vision Institute
Colorado Springs, Colorado, 80907
Piedmont Eye Center
Lynchburg, Virginia, 24502
Total Eye Care, PA
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167
About this study
Official title: A Phase 3b Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).
Read the detailed description
Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).
- Conditions
- Dry Eye Disease
- Being tested
- 0.003% AR-15512 ophthalmic solution, Artificial tears
- Keywords
- Dry Eyes
- 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 topically in 4 different instillation variations: 512-RT (0.003% AR-15512 instilled at room temperature, eyes to remain open post-drop instillation); 512-COLD (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator, eyes to remain open post-drop instillation); 512-RT-EC (0.003% AR-15512 instilled at room temperature followed by subjects immediately closing their eyes); and 512-COLD-EC (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator followed by subjects immediately closing their eyes).
Artificial tearsDrug
Also called REFRESH® Classic
Commercially available, preservative-free lubricant eye drops administered topically
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. Receives: Drug: 0.003% AR-15512 ophthalmic solution; Drug: Artificial tears |
| Sequence 2 | Other | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. Receives: Drug: 0.003% AR-15512 ophthalmic solution; Drug: Artificial tears |
| Sequence 3 | Other | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. Receives: Drug: 0.003% AR-15512 ophthalmic solution; Drug: Artificial tears |
| Sequence 4 | Other | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. Receives: Drug: 0.003% AR-15512 ophthalmic solution; Drug: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention
Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint.
Measured: Up to Day 1 post drop instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 Jan 2025
- Primary completion6 Feb 2025
- Study completion6 Feb 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, Pharma, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660290
- Sponsor's protocol ID
- DEF512-E005
- Status last verified
- Mar 2026
- First submitted
- 24 Oct 2024
- Last updated
- 17 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
- ClinicalTrials.gov ID
- NCT06660290
- Acronym / sponsor ID
- DEF512-E005
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eyes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Posted 17 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 percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).
Detailed description
Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: 0.003% AR-15512 ophthalmic solution, Drug: Artificial tearsOne drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| Sequence 2 | Other | Drug: 0.003% AR-15512 ophthalmic solution, Drug: Artificial tearsOne drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| Sequence 3 | Other | Drug: 0.003% AR-15512 ophthalmic solution, Drug: Artificial tearsOne drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| Sequence 4 | Other | Drug: 0.003% AR-15512 ophthalmic solution, Drug: Artificial tearsOne drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
- Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
- Capable of giving signed informed consent.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Current evidence of other clinically significant ophthalmic disease other than dry eye;
- History of ocular surgery within 1 year of the Study Visit;
- Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
- Positive pregnancy test or currently breastfeeding.
- Other protocol-defined exclusion criteria may apply.
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 topically in 4 different instillation variations: 512-RT (0.003% AR-15512 instilled at room temperature, eyes to remain open post-drop instillation); 512-COLD (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator, eyes to remain open post-drop instillation); 512-RT-EC (0.003% AR-15512 instilled at room temperature followed by subjects immediately closing their eyes); and 512-COLD-EC (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator followed by subjects immediately closing their eyes). | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Artificial tearsAlso: REFRESH® ClassicCommercially available, preservative-free lubricant eye drops administered topically | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention
Time frame: Up to Day 1 post drop instillation
Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Sr. Clinical Trial Lead, Pharma study director
Alcon Research, LLC
6 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 6 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 4 inclusion and 5 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 17 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 6 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 17 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?
Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention (time frame: Up to Day 1 post drop 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 17 Mar 2026.