MedTrace Logo

Autologous Plasma Treatment for Severe Dry Eye Patients

NCT03768115 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-10-22

No results posted yet for this study

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

Interventions

DRUG

Autologous Plasma Eye Drop

Autologous plasma crimped segments

Sponsors & Collaborators

  • Health Science Authority Singapore

    collaborator UNKNOWN

  • Singapore National Eye Centre

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-10-14
Completion
2020-10-14

Countries

  • Singapore

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768115 on ClinicalTrials.gov