New eye drops aim to improve corneal transplant outcomes in fuchs dystrophy
NCT ID NCT07024693
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental eye drop called DT-168 in people with Fuchs endothelial corneal dystrophy who are already scheduled for a corneal transplant. The goal is to see if the drops are safe and affect disease-related markers. About 28 adults aged 30 and older with a specific genetic change will take part.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study. * ≥30 years of age (inclusive). * Documented diagnosis of FECD in the study eligible eye. * Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele. * Capable of giving signed informed consent. Exclusion Criteria: * Any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation. * Any clinically significant medical, nonmedical, and psychiatric disorders that could put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator. * Concurrent or anticipated need for treatment for FECD, eg, Muro 128 (2% or 5%) during the course of the study in the study eye. Provided the subject undergoes a washout of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded. * Concurrent or anticipated use of topical corticosteroids in the study eye. * Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor. * Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study. * Use of contact lenses in the study eye within 7 days prior to the Baseline Visit or planned use during the study. * Recent (within 30 days of the Screening Visit) or ongoing participation in any other investigational interventional clinical study. * Female participant is pregnant, planning a pregnancy, or breast-feeding. * Participant is unwilling to comply with the contraceptive requirements, as per protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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DTX-168-201 Study Site
RECRUITINGIndianapolis, Indiana, 46260, United States
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DTX-168-201 Study Site
RECRUITINGGrand Rapids, Michigan, 49546, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Eye drops may shield the cornea after cataract surgery
- Can eye drops offer a new way to treat fuchs dystrophy?
- Fuchs dystrophy and cataract surgery: does the cornea behave differently?
- One shot to see clearly: cell therapy takes on corneal edema
- Which corneal transplant is best? 1,000-Patient study aims to find out
- Corneal polishing study aims to improve cell therapy for fuchs dystrophy