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

NCT07529899 | Not Yet Recruiting Phase 3

• 1 other identifier: CELLBIO-2026-003
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dry Eye Disease (DED)

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improvement in Patient Reported Symptoms

  6-8 weeks

• Stability of Tear Film

  6-8 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

FD-AM + SoC

EXPERIMENTAL

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).

Procedure: Standard of Care (SOC); Other: Lyophilized Amnion Membrane Disc Allograft

Interventions

Standard of Care (SOC) PROCEDURE

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.

FD-AM + SoC

Lyophilized Amnion Membrane Disc Allograft OTHER

Lyophilized Amnion Membrane Disc Allograft derived from donated human tissues.

FD-AM + SoC; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Corneal Fluorescein Staining (CFS) Modified NEI grade \> 15 in the study eye.
• Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
• Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months.
• Participant must be able to follow study instructions, with the intention of completing all required visits
• Participant must agree to attend the study visits required by the protocol.
• Participant must be able and willing to complete follow-up.
• Participant must be willing and able to participate in the informed consent process.

You may not qualify if:

• Presence of persistent corneal epithelial defect or ulcer in either eye
• Presence of active ocular infection in either eye
• Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis
• Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis
• Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)
• Contact lens wear
• History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
• Presence of cicatricial ocular surface diseases
• 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
• History or use of any medications listed in 6.7.2 within the specified washout period
• Ophthalmic use of amniotic membrane in the past 90 days.

Sponsors & Collaborators

• Cellution Biologics: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Research Director

  Cellution Biologics

  STUDY DIRECTOR

Central Study Contacts

Bryanna Finstein

CONTACT

6035574660; bryanna.f@cellutionbiologics.com

Cellution Research

CONTACT

6035574660; clinical@cellutionbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share