CClinicalTrials.gg
RecruitingNCT07277257Updated Dec 22, 2025

Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome

A Phase 4 interventional study of TRYPTYR (Acoltremon ophthalmic solution 0.003%) in Sjogren Syndrome With Keratoconjunctivitis, sponsored by Center For Sight. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Center For Sight · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sjogren Syndrome With Keratoconjunctivitis
03

In context

Lead sponsor

Center For Sight is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subjects must fulfill the following conditions to qualify for enrollment into the trial

  1. Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.
  2. History of using or desiring artificial tears for DED symptoms within the past 2 months.
  3. 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).

Exclusion criteria

Exclusion Criteria:

Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.

  1. History of ocular surgery within the past 6 months.
  2. Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study
  3. On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.
  4. Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.
  5. Use of artificial tears within 2 hours prior to the baseline or study visit days.
  6. Any known allergies to any component of the study drug.
  7. 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Study eye

    The study eye is the eye with the lower pre-drop unanesthetized Schirmer score performed at the baseline visit.

    Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)

Interventions

  • DrugTRYPTYR (Acoltremon ophthalmic solution 0.003%)

    Drop to be instilled before and after endpoint measurement.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 minutes

07

Study locations

1 of 1 sites recruiting
  • Center For Sight
    Venice, Florida 34285, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07277257
Lead sponsor
Center For Sight
Responsible party
Sponsor
First posted
Dec 11, 2025
Start date
Dec 2, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 22, 2025

Study contacts

Gina Thomas
Contact
gina.thomas@useye.com
9412634784

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion