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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellution Biologics

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

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators