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Autologous Plasma Treatment for Severe Dry Eye Patients

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ClinicalTrials.gov Identifier: NCT03768115
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Health Science Authority Singapore
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Autologous Plasma Eye Drop Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Autologous crimped plasma segments
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Autologous Plasma Eyedrops Therapy for Severe Dry Eye in Singapore
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Intervention Details:
  • Drug: Autologous Plasma Eye Drop
    Autologous plasma crimped segments


Primary Outcome Measures :
  1. Change from baseline dry eye symptoms at 1 year [ Time Frame: 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).




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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768115


Contacts
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Contact: Louis Tong, PhD 65767200 louis.tong.h.t@singhealth.com.sg
Contact: Cynthia Boo, BSc 65767200 cynthia.boo.s.k@seri.com.sg

Locations
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Singapore
Singapore Eye Research Institute Recruiting
Singapore, Singapore, 169856
Contact: Cynthia Boo, BSc    65767200    cynthia.boo.s.k@seri.com.sg   
Principal Investigator: Louis Tong, PhD         
Sponsors and Collaborators
Singapore National Eye Centre
Health Science Authority Singapore

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Responsible Party: Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT03768115     History of Changes
Other Study ID Numbers: R945/54/2012
2018/2855 ( Registry Identifier: SingHealth CIRB )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases