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NCT07529899

PHASE4

Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft vs Standard of Care in Participants With Dry Eye Disease

Sponsor: Cellution Biologics

View on ClinicalTrials.gov

Summary

To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.

Official title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft Versus Standard of Care in Participants With Moderate to Severe Dry Eye Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09

Completion Date

2027-12

Last Updated

2026-08-06

Healthy Volunteers

Conditions

Dry Eye Disease (DED)

Interventions

PROCEDURE

Standard of Care (SOC)

Standard of care is to perform eye cleansing with sterile saline, application of one drop of Ofloxacin prophylactically to eye, application of topical anesthetic, application of bandage lens to eye, application of drops of saline as needed to ensure hydration, taping eye partially shut and continuation of preservative free topical lubricating drops.

OTHER

Lyophilized Amnion Membrane Disc Allograft

Lyophilized Amnion Membrane Disc Allograft derived from donated human tissues.

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.