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 (BLINK)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Other: Lyophilized Amnion Membrane Disc Allograft; Procedure: Standard of Care (SOC)

Detailed Description

Dry Eye Disease (DED) is a chronic, progressive inflammatory multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film. It is accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. DED creates a vicious cycle of ocular surface inflammation and damage. Beyond simple 'dryness', DED is recognized as a chronic, potentially progressive condition that can lead to significant visual impairment, corneal scarring, and a diminished quality of life (QoL) comparable to moderate-to-severe angina or dialysis.

While standard therapies (lubricants, anti-inflammatory agents) manage symptoms, many patients suffer from refractory epithelial defects and keratitis. Human Amniotic Membrane (HAM) has been shown to possess anti-inflammatory, anti-scarring, and epithelial-promoting properties. The Human Amniotic Membrane (HAM) is the innermost layer of the placenta. It is uniquely suited for ocular surface reconstruction due to its complex biological scaffold.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cellution Research; Phone Number: 6035574660; Email: clinical@cellutionbiologics.com
• Study Contact Backup: Name: Bryanna Finstein; Phone Number: 6035574660; Email: bryanna.f@cellutionbiologics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage).	Other: Lyophilized Amnion Membrane Disc Allograft; Lyophilized Amnion Membrane Disc Allograft derived from donated human tissues.
Experimental: FD-AM + SoC; Participants with dye eye disease will receive treatment with a Freeze-Dried Amnionic Membrane product and treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage).	Other: Lyophilized Amnion Membrane Disc Allograft; Lyophilized Amnion Membrane Disc Allograft derived from donated human tissues.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Corneal Epithelial Damage	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.	6-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Patient Reported Symptoms	To evaluate improvement in patient reported symptoms (OSDI).	6-8 weeks
Stability of Tear Film	To assess the stability of the tear film (TBUT).	6-8 weeks

Collaborators and Investigators

• Sponsor: Cellution Biologics
• Investigators: Study Director: Research Director, Cellution Biologics

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dry Eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: CELLBIO-2026-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No