Not Yet RecruitingPhase 3

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

40 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 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.

Exclusion criteria

✕. 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

What they're measuring

Reduction of Corneal Epithelial Damage

Timeframe: 6-8 weeks

Trial details

NCT IDNCT07529899

SponsorCellution Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Bryanna Finstein

6035574660 bryanna.f@cellutionbiologics.com

View on ClinicalTrials.gov More Dry Eye Disease (DED) trials