Evaluation of the Clinical Efficacy and Mechanisms of Cord Plasma Eye Drops in the Treatment of N… (NCT07566806) | Clinical Trial Compass
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Evaluation of the Clinical Efficacy and Mechanisms of Cord Plasma Eye Drops in the Treatment of Neuropathic Corneal Pain
Singapore20 participantsStarted 2023-09-16
Plain-language summary
The goal of this clinical trial is to investigate the efficacy and work of action of cord plasma eye drops in the treatment of neuropathic corneal pain (NCP). The main question it aims to answer if the cord plasma eye drops are effective for the treatment of NCP through its neurotrophic and anti-neuroinflammatory effects.
Who can participate
Age range
21 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
. Persistent ocular pain or pain-like symptoms, including burning sensation, allodynia, photoallodynia, stinging, hyperalgesia, throbbing, shooting, sharp, cramping, gnawing, or a feeling of electric shock, with a minimum score of 30% for more than 3 questions in the OPAS questionnaire (see below section for OPAS questionnaire), for at least 3 months;
. Presence of corneal nerve abnormalities, including microneuromas, beading, nerve tortuosity, decreased in corneal nerve fiber density (CNFD) or corneal nerve fiber length (CNFL), on IVCM images;
. Minimal or no ocular surface fluorescein staining, with the National Eye Institute (NEI) and ocular surface Oxford score \<2;
. Patients who will receive cord plasma eye drops treatment
Exclusion criteria
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.
1Since this trial is using cord plasma eye drops — a treatment made from umbilical cord blood — what do we know so far about its safety profile for use directly on the eye, and are there any risks I should be aware of before considering it?
2The trial measures my pain using something called the Ocular Pain Assessment Survey — how will my responses on that questionnaire actually influence my treatment during the study, and what happens if my pain gets significantly worse while I'm enrolled?
3This trial also uses in vivo confocal microscopy to look at the nerves in my cornea — is that imaging process itself safe and comfortable, and would those results give me useful information about my condition beyond the study?
4Since this is listed as Phase NA, meaning it may be exploratory or early-stage, does that mean there's less established evidence about whether cord plasma eye drops actually work for neuropathic corneal pain compared to treatments that have gone through standard phase trials?
5Are there any existing or standard treatments for neuropathic corneal pain — like autologous serum eye drops or other nerve-targeted therapies — that I should try first before considering an experimental approach like this one?
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.
What they're measuring
1
Pain symptoms evaluated by Ocular Pain Assessment Survey (OPAS) questionnaire
Timeframe: 3 months
2
Corneal nerve morphology assessment by in vivo confocal microscopy (IVCM)
. Presence of active ocular surface diseases, such as active infective keratitis, the presence of epithelial defect or any other conditions that may cause nociceptive pain
. Active anterior or posterior blepharitis;
. Presence of concomitant ocular diseases that may cause ocular pain, such as uveitis or other ocular inflammatory diseases;
. Concurrent treatment with immunosuppressants, such as topical cyclosporin or steroid eye drops
. Concurrent use of oral Nonsteroidal anti-inflammatory drugs (NSAID) or other medications that may affect the pain scores