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New eye drop aims to bring tears to dry eyes in Sjögren's patients

NCT ID NCT07277257

Symptom relief Sponsor: Center For Sight Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether TRYPTYR eye drops can quickly improve tear production in people with dry eye from Sjögren's syndrome. About 35 adults will receive the drops and have their tear levels measured before and after. The goal is to see if this treatment can ease dry eye symptoms in this specific group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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.

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sjogren syndrome with keratoconjunctivitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center For Sight

    RECRUITING

    Venice, Florida, 34285, United States

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