NCT07529899

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cellution Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-14