Could a disc made from donated tissue ease severe dry eye?
NCT ID NCT07529899
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 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: 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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