Dry Eye Disease (DED)Phase 4NCT07732010
TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)
A Phase 4 study testing TRYPTYR (Acoltremon ophthalmic solution 0.003%) in people with Dry Eye Disease (DED), run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effectiveness of TRYPTYR as a treatment for Dry Eye Disease. The primary efficacy variable is change from baseline in the Ocular Surface Disease Index (OSDI) at week 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- TRYPTYR (Acoltremon ophthalmic solution 0.003%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2026to 25 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Adults (18 and older)
- Ability to provide informed consent and to understand the study procedures
- Patients diagnosed with dry eye disease
- Presence of dry eye symptoms determined by a validated questionnaire (OSDI- Attachment 1) with scores above a specified threshold AND
- Tear film break-up time (TBUT) below a set value (less than 8 seconds)
- Schirmer test (w/o drops) value below a set cut-off (less than 10 mm)
Show all 9Show fewer
- Positive findings on ocular surface staining (NEI >/equal 3)
- Positive conjunctival staining (NEI >4)
- Moderate meibomian gland dysfunction (MGD)
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
- History of ocular surgery within 3 months prior to the Screening visit, including punctal cautery, corneal refractive, or anterior segment surgeries that affect corneal sensitivity (e.g., cataract surgery or any surgery involving limbal or corneal incision) or lid surgery
- Have had a corneal transplant in either or both eyes
- Patients with current steroid use
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Single Center Investigator Initiated Trial Using TRYPTYR as a Treatment for Patients With Dry Eye Disease
The purpose of this research study is to determine the effectiveness of TRYPTYR as a treatment for Dry Eye Disease. The primary efficacy variable is change from baseline in the Ocular Surface Disease Index (OSDI) at week 2. The co-primary efficacy variables are change from baseline in the National Eye Institute (NEI) scale of the cornea and NEI scale of the conjunctiva at 1 month (the third visit).
- Conditions
- Dry Eye Disease (DED)
- Being tested
- TRYPTYR (Acoltremon ophthalmic solution 0.003%)
- Keywords
- DED, TRYPTYR
- 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.
TRYPTYR (Acoltremon ophthalmic solution 0.003%)Drug
TRYPTYR will be administered one drop in each eye twice daily (once every 12 hours) for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye Disease | Experimental | Participants will be treated with the TRYPTYR drug for one month Receives: Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocular surface disease index (OSDI) Score
The Ocular Surface Disease Index (OSDI) is a 12-question screening tool used to measure the severity of dry eye disease and how it affects vision. Scores range from 0 to 100, with higher numbers indicating more severe symptoms.
Measured: Baseline, Week 2
Change in National Eye Institute (NEI) scale of the cornea
The NEI scale of the cornea is a standardized system used to grade corneal fluorescein staining. It evaluates punctate epithelial erosions (staining) across five specific corneal zones (superior, inferior, nasal, temporal, and central) to yield a total severity score. Each of the 5 zones is graded on an integer scale from 0 (No staining) to 3 (Severe or confluent staining). Total scores of 0-5 typically indicate mild surface disease, 6-10 represent moderate disease, and 11-15 indicate severe ocular surface disease.
Measured: Baseline, 1 Month
Change in NEI scale of the conjunctiva
The National Eye Institute (NEI) scale of the conjunctiva evaluates the ocular surface by dividing the conjunctiva into six specific areas for evaluation to grade staining. Each of these six regions is graded individually on a 0 (none) to 3 (severe) scale. By adding the scores of all six regions, the conjunctiva yields a total score ranging from 0 to 18. Low scores represent a healthy or mildly compromised ocular surface, whereas high scores indicate severe surface disease like dry eye
Measured: Baseline, 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start6 Jul 2026
- Primary completion20 Apr 2027 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giacomina Massaro-Giordano, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732010
- Sponsor's protocol ID
- 26-00319
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: he de-identified participant data from the final research dataset will not be shared. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Investigator Initiated Trial Using TRYPTYR as a Treatment for Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07732010
- Acronym / sponsor ID
- 26-00319
- Conditions
- Dry Eye Disease (DED)
- Keywords
- DED, TRYPTYR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
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 research study is to determine the effectiveness of TRYPTYR as a treatment for Dry Eye Disease. The primary efficacy variable is change from baseline in the Ocular Surface Disease Index (OSDI) at week 2. The co-primary efficacy variables are change from baseline in the National Eye Institute (NEI) scale of the cornea and NEI scale of the conjunctiva at 1 month (the third visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Disease | Experimental | Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)Participants will be treated with the TRYPTYR drug for one month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults (18 and older)
- Ability to provide informed consent and to understand the study procedures
- Patients diagnosed with dry eye disease
- Presence of dry eye symptoms determined by a validated questionnaire (OSDI- Attachment 1) with scores above a specified threshold AND
- Tear film break-up time (TBUT) below a set value (less than 8 seconds)
Key exclusion criteria (5 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
- History of ocular surgery within 3 months prior to the Screening visit, including punctal cautery, corneal refractive, or anterior segment surgeries that affect corneal sensitivity (e.g., cataract surgery or any surgery involving limbal or corneal incision) or lid surgery
- Have had a corneal transplant in either or both eyes
- Patients with current steroid use
- Pregnancy
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 |
|---|---|---|
| TRYPTYR (Acoltremon ophthalmic solution 0.003%)TRYPTYR will be administered one drop in each eye twice daily (once every 12 hours) for 30 days. | Drug | Dry Eye Disease |
Primary outcome
Change in ocular surface disease index (OSDI) Score
Time frame: Baseline, Week 2
The Ocular Surface Disease Index (OSDI) is a 12-question screening tool used to measure the severity of dry eye disease and how it affects vision. Scores range from 0 to 100, with higher numbers indicating more severe symptoms.
Change in National Eye Institute (NEI) scale of the cornea
Time frame: Baseline, 1 Month
The NEI scale of the cornea is a standardized system used to grade corneal fluorescein staining. It evaluates punctate epithelial erosions (staining) across five specific corneal zones (superior, inferior, nasal, temporal, and central) to yield a total severity score. Each of the 5 zones is graded on an integer scale from 0 (No staining) to 3 (Severe or confluent staining). Total scores of 0-5 typically indicate mild surface disease, 6-10 represent moderate disease, and 11-15 indicate severe ocular surface disease.
Change in NEI scale of the conjunctiva
Time frame: Baseline, 1 Month
The National Eye Institute (NEI) scale of the conjunctiva evaluates the ocular surface by dividing the conjunctiva into six specific areas for evaluation to grade staining. Each of these six regions is graded individually on a 0 (none) to 3 (severe) scale. By adding the scores of all six regions, the conjunctiva yields a total score ranging from 0 to 18. Low scores represent a healthy or mildly compromised ocular surface, whereas high scores indicate severe surface disease like dry eye
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. he de-identified participant data from the final research dataset will not be shared. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Giacomina Massaro-Giordano, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TRYPTYR (Acoltremon ophthalmic solution 0.003%) in people with Dry Eye Disease (DED), run by NYU Langone Health 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 9 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: looking for participants now, as of the sponsor's last update on 28 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamika Singleton-Garvin (929-455-5522, Jamika.Singleton-Garvin@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ocular surface disease index (OSDI) Score (time frame: Baseline, Week 2). The study lists 3 primary outcomes in all. 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 28 Jul 2026.