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Could a disc made from donated tissue ease severe dry eye?

NCT ID NCT07529899

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 4 times

Summary

This Phase 3 trial tests whether a disc made from donated human amnion membrane can help people with moderate to severe dry eye disease. The disc is placed on the eye and compared to standard care like lubricating drops and a bandage lens. The study will enroll 40 adults who have not gotten relief from artificial tears.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lyophilized Amnion Membrane Disc Allograft (derived from donated human tissue)
What this could lead to
If it works, this could offer a new treatment option for people with moderate to severe dry eye disease who haven't responded to standard therapies.
What could go wrong
This is a small early-stage trial with only 40 participants, so results may not apply to everyone. The treatment involves a disc placed on the eye, which may cause discomfort or infection.

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.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

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: 1. 18 years of age or older. 2. Corneal Fluorescein Staining (CFS) Modified NEI grade \> 15 in the study eye. 3. Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye 4. Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months. 5. Participant must be able to follow study instructions, with the intention of completing all required visits 6. Participant must agree to attend the study visits required by the protocol. 7. Participant must be able and willing to complete follow-up. 8. Participant must be willing and able to participate in the informed consent process. Exclusion Criteria: 1. Presence of persistent corneal epithelial defect or ulcer in either eye 2. Presence of active ocular infection in either eye 3. Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis 4. Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis 5. Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD) 6. Contact lens wear 7. History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK 8. Presence of cicatricial ocular surface diseases 9. History of procedures listed in 6.7.1 within the specified washout period CONFIDENTIAL Version No. 1 Version Date 06APR2026 Page PAGE 67 of NUMPAGES 67 VERSION 1.0 CELLUTION BIOLOGICS INC. 06 APRIL 2026 10. History or use of any medications listed in 6.7.2 within the specified washout period 11. Ophthalmic use of amniotic membrane in the past 90 days. 12. Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception. 13. Medical or psychological condition that, in the opinion of the investigator, may interfere with study. 14. Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics. 15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

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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.

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