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

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.

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
• History of procedures listed in 6.7.1 within the specified washout period

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• 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.
• 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.
• Medical or psychological condition that, in the opinion of the investigator, may interfere with study.
• Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
• Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.