Autologous Plasma Treatment for Severe Dry Eye Patients

NCT03768115 | Withdrawn Early Phase 1

• 2 other identifiers: R945/54/20122018/2855
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Change from baseline dry eye symptoms at 1 year

  A Visual Analogue Scale (VAS) will be applied to evaluate dry eye symptoms as described by Schaumberg et al. (Schaumberg 2007). As shown in Appendix B , the scores will be recorded separately for frequency and severity of dry eye symptoms. The patient will be asked to check a point on a 100-mm line that corresponds to the degree of the symptom. The location of the mark made by the patient for each question will be measured in mm from the left hand side of the 100 mm line and recorded in mm. For the follow up visits, which measured the distance between the mark made by the patient and the central anchor, a negative value will be recorded if left of the anchor and a positive value if right of the anchor. The higher the number, implying more symptoms and frequency of experiencing dry eye. A global score will be calculated by multiplying the frequency score by the severity score and taking the square root of the result (to transform back to the original scale).

  1 year

Interventions

Autologous Plasma Eye Drop DRUG

Autologous plasma crimped segments

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with dry eye symptoms, who cannot be satisfactorily managed by currently available dry eye medication
• TBUT ≤10s
• Presence of corneal fluorescein staining
• Visual acuity affected by poor tear film quality
• No contraindication for blood extraction/ plasmapheresis
• Age between 21 to 99 years old
• 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.

You may not qualify if:

• Active ocular infection.
• Any other specified reason as determined by clinical investigator
• Severe cardiovascular disease
• Severe respiratory disease
• Uncontrolled epilepsy
• Abnormal bleeding conditions
• Pregnancy
• 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.
• Patients who have been or are being treated for bacteraemia, or have a significant bacterial infection that can be associated with bacteraemia.
• 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.
• 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.
• Patients with persistent epithelial defect that requires bandage contact lens

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Health Science Authority Singapore: collaborator

Study Sites (1)

Singapore Eye Research Institute

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist, Senior Consultant

Model Details: Autologous crimped plasma segments

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 7, 2018
• Study Start: November 1, 2018
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)