About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Standard of Care (SOC)
- Lyophilized Amnion Membrane Disc Allograft