Sjogren Syndrome With KeratoconjunctivitisPhase 4NCT07277257
Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome
A Phase 4 study testing TRYPTYR (Acoltremon ophthalmic solution 0.003%) in people with Sjogren Syndrome With Keratoconjunctivitis, run by Center For Sight at 1 site in United States.
Trial summary
This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren Syndrome With Keratoconjunctivitis
- What is being tested?
- TRYPTYR (Acoltremon ophthalmic solution 0.003%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to 31 Dec 2026
- 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
- Subjects must fulfill the following conditions to qualify for enrollment into the trial
- Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.
- History of using or desiring artificial tears for DED symptoms within the past 2 months.
- Unanesthetized Schirmer's Test (UA ST) score ≥1 and < 10 mm/5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National Eye Institute, NEI, grading scale).
Who cannot join
- Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- History of ocular surgery within the past 6 months.
- Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study
- On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.
- Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.
- Use of artificial tears within 2 hours prior to the baseline or study visit days.
- Any known allergies to any component of the study drug.
- Severe, uncontrolled autoimmune disease (e.g., rheumatoid arthritis, lupus). Uncontrolled is at the discretion of the PI. Subjects with severe systemic symptoms will not be included.
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
Center For Sight
Venice, Florida, 34285
Gina Thomas, 941-263-4784, gthomas@centerforsight.net
About this study
Official title: Evaluating TRYPTYR as a Novel Therapy for Dry Eye in Patients With Sjögren's Syndrome
This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population.
- Being tested
- TRYPTYR (Acoltremon ophthalmic solution 0.003%)
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
Drop to be instilled before and after endpoint measurement.
| Study group | Role | What they receive |
|---|---|---|
| Study eye | Experimental | The study eye is the eye with the lower pre-drop unanesthetized Schirmer score performed at the baseline visit. 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 from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline)
Unanesthetized Schirmer's test will be measured prior to instillation and then again 3 minutes after instillation of the TRYPTYR. The difference between the 2 measurements will be compared.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start2 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren Syndrome With KeratoconjunctivitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center For Sight
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277257
- Sponsor's protocol ID
- CFS25-004
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating TRYPTYR as a Novel Therapy for Dry Eye in Patients With Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT07277257
- Acronym / sponsor ID
- CFS25-004
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Center For SightUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2025 (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.
This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study eye | Experimental | Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)The study eye is the eye with the lower pre-drop unanesthetized Schirmer score performed at the baseline visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must fulfill the following conditions to qualify for enrollment into the trial
- Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.
- History of using or desiring artificial tears for DED symptoms within the past 2 months.
- Unanesthetized Schirmer's Test (UA ST) score ≥1 and < 10 mm/5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National Eye Institute, NEI, grading scale).
Key exclusion criteria (8 listed)
- Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- History of ocular surgery within the past 6 months.
- Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study
- On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.
- Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.
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%)Drop to be instilled before and after endpoint measurement. | Drug | Study eye |
Primary outcome
Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline)
Time frame: 3 minutes
Unanesthetized Schirmer's test will be measured prior to instillation and then again 3 minutes after instillation of the TRYPTYR. The difference between the 2 measurements will be compared.
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 22 Dec 2025.
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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.
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 Sjogren Syndrome With Keratoconjunctivitis, run by Center For Sight 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 4 inclusion and 8 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 22 Dec 2025. 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 Gina Thomas (9412634784, gina.thomas@useye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline) (time frame: 3 minutes). 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 22 Dec 2025.