Autologous Plasma Treatment for Severe Dry Eye Patients

• Status: Withdrawn
• Trial end date: 2020-10-14
• Target enrollment: 0
• Participant gender: All

Summary

Patients with severe dry eye who have exhausted conventional treatment are not uncommon and are difficult to manage. They and their physicians are helpless when faced with these scenarios. A small HPRG group, Health Science Authority (HSA) and IRB approved study of autologous plasma eye drop therapy for patients with recalcitrant dry eye has been completed recently by investigators at the Singapore National Eye Centre. The unique feature of the previous protocol was that the autologous plasma preparation was made and contained in sealed segments of intravenous tubing until use by the patient. The study showed that the corneal fluorescein staining of patients who regularly used autologous plasma over a 6 week period improved significantly. Additionally, there was a significant reduction in the total number of topical eye drop treatment required. Investigator did not encounter any cases of infected eye drop preparation or any cases of eye infection. Seventy percent of these patients would recommend this treatment to their relatives and friends suggesting that this form of treatment is a valuable additional modality for dry eyes. Now, investigator would like to extend the short-term pilot study into a long-term single arm clinical trial, in order to determine the best protocol/logistic for this treatment that is practical and still effective, and allowing for more than one plasmapheresis during the study. To achieve this, investigator aim to perform a longitudinal prospective study of patients with severe dry eye who cannot be satisfactorily managed with conventional dry eye treatments using a proposed regime for plasmapheresis and plasma storage.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Singapore National Eye Centre
• Collaborator: Health Science Authority Singapore
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

1. Patients with dry eye symptoms, who cannot be satisfactorily managed by currently available dry eye medication

2. TBUT ≤10s

3. Presence of corneal fluorescein staining

4. Visual acuity affected by poor tear film quality

5. No contraindication for blood extraction/ plasmapheresis

6. Age between 21 to 99 years old

7. Skin lesions - The skin at the site of venepuncture in the antecubital area should be free of lesions. Donors with boils, open wounds, chronic eczema or any severe skin infection must be rejected.

Exclusion Criteria:

1. Active ocular infection.

2. Any other specified reason as determined by clinical investigator

3. Severe cardiovascular disease

4. Severe respiratory disease

5. Uncontrolled epilepsy

6. Abnormal bleeding conditions

7. Pregnancy

8. Infectious diseases

• Patients who are known or diagnosed to have HIV, Hepatitis B or Hepatitis C carriers should not be accepted for donation.

• Patients who have risk factors for infectious diseases should not be accepted for donation.

9. Patients who have been or are being treated for bacteraemia, or have a significant bacterial infection that can be associated with bacteraemia.

10. Unable to come for follow up at the required frequencies and duration. This includes non-Singapore residents who are patients of the dry eye clinic.

11. In order to avoid serious infections, especially corneal keratitis, we will not include patients with high risks for infection in this study, such as those patients with a persistent epithelial defect, wearing of contact lenses, previous ocular surgery such as penetrating keratoplasty or any other ocular surgery.

12. Patients with persistent epithelial defect that requires bandage contact lens