Evaluation of the Clinical Efficacy and Mechanisms of Cord Plasma Eye Drops in the Treatment of Neuropathic Corneal Pain

NCT07566806 | Recruiting DMC

• 1 other identifier: 2023-2597
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain; Corneal Disease

Keywords

Neuropathic corneal pain; Cord plasma eye drops; Blood-derived eye drops; Corneal nerves; Tear mediators

Outcome Measures

Primary Outcomes (2)

• Pain symptoms evaluated by Ocular Pain Assessment Survey (OPAS) questionnaire

  Ocular pain will be assessed using the Ocular Pain Assessment Survey (OPAS) questionnaire. The Ocular Pain Assessment Survey (OPAS) is a 27-item questionnaire to evaluate the eye pain from 6 dimensions, including pain intensity for the last 24h, pain intensity for the last 2 weeks, non-eye pain intensity, quality of life, aggravating factors, associated factors and symptom relief. Each question was scored on a scale of 0-10 or 100%, with higher score representing worse pain.

  3 months

• Corneal nerve morphology assessment by in vivo confocal microscopy (IVCM)

  IVCM (Heidelberg Retina Tomography III. Rostock Cornea Module, Heidelberg Engineering GmbH) will be used to examine the subbasal nerve plexus. The images will be analyzed using ACCMetrics software and get the quantitative nerve parameters.

  3 months

Secondary Outcomes (9)

• Tear neuromediator levels

  3 months

• Ocular Surface Disease Index (OSDI) questionnaire to measure eye symptoms and the impact of quality of life.

  3 months

• Amount of tear production measured by Schirmer's I test

  3 months

• Corneal sensitivity measurements assessed by Cochet-Bonnet esthesiometer

  3 months

• Tear film stability

  3 months

Study Arms (1)

Patients with NCP

EXPERIMENTAL

Patients who have been advised and scheduled to receive cord plasma eye drops treatment for their NCP will be recruited. The NCP will be diagnosed based on the following criteria.

Drug: Cord plasma eye drops

Interventions

Cord plasma eye drops DRUG

SNEC has collaborated with Singapore Cord Blood Bank to provide cord blood plasma service, and cord blood plasma eye drops have been used as standard clinical care for patients with ocular surface diseases, severe dry eye, and NCP in SNEC.

Patients with NCP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Eye Research Institute: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore, 169856, Singapore

RECRUITING

Related Publications (6)

• Dieckmann G, Goyal S, Hamrah P. Neuropathic Corneal Pain: Approaches for Management. Ophthalmology. 2017 Nov;124(11S):S34-S47. doi: 10.1016/j.ophtha.2017.08.004.

  PMID: 29055360 BACKGROUND

• Gendrel D, Nardou M, Mouba JF, Gahouma D, Moussavou A, Boguikouma JB. [Hepatotoxicity of the combination of isoniazid-rifampicin in African children. Role of malnutrition and HB virus]. Arch Fr Pediatr. 1989 Nov;46(9):645-8. French.

  PMID: 2604523 BACKGROUND

• Aggarwal S, Colon C, Kheirkhah A, Hamrah P. Efficacy of autologous serum tears for treatment of neuropathic corneal pain. Ocul Surf. 2019 Jul;17(3):532-539. doi: 10.1016/j.jtos.2019.01.009. Epub 2019 Jan 24.

  PMID: 30685437 BACKGROUND

• Wong J, Govindasamy G, Prasath A, Hwang W, Ho A, Yeo S, Tong L. Allogeneic Umbilical Cord Plasma Eyedrops for the Treatment of Recalcitrant Dry Eye Disease Patients. J Clin Med. 2023 Oct 25;12(21):6750. doi: 10.3390/jcm12216750.

  PMID: 37959215 BACKGROUND

• Anam A, Liu C, Tong L, Liu YC. Blood-Derived Eye Drops for the Treatment of Corneal Neuropathic Pain. J Ocul Pharmacol Ther. 2024 Jun;40(5):281-292. doi: 10.1089/jop.2023.0155. Epub 2024 Apr 22.

  PMID: 38648544 BACKGROUND

• Norkett B. The role of nursing in marketing health care. Nurs Adm Q. 1985 Fall;10(1):85-9. doi: 10.1097/00006216-198510010-00009. No abstract available.

  PMID: 3852115 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Corneal Diseases

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases

Central Study Contacts

Yu-Chi Liu, PhD

CONTACT

65 65767493; liu.yu.chi@snec.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: May 5, 2026
• Study Start: September 16, 2023
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)