Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft vs Standard of Care in Partici… (NCT07529899) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft vs Standard of Care in Participants With Dry Eye Disease
50 participantsStarted 2026-09
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses an amnion membrane disc allograft — a tissue-based treatment — instead of the eye drops or other standard care I might already be using; can you explain what that actually involves and how it would be placed in or on my eye?
2Since this is a Phase 3 trial, what do we already know about how safe and effective the amnion membrane disc allograft has been in earlier studies, and are there any risks I should weigh carefully before considering it?
3The trial is not yet recruiting, so if I'm dealing with moderate to severe dry eye disease right now, what standard-of-care options should we start with while I wait to see if this trial opens near me?
4The primary outcome they're measuring is reduction of corneal epithelial damage — can you tell me how damaged my corneal epithelium currently is, and whether my case is a good fit for what this trial is designed to study?
5This is a randomized controlled trial, which means I might be assigned to the standard-of-care group rather than the amnion membrane treatment — how would that affect my care compared to what you'd recommend for me outside of a trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.