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Umbilical Cord Serum Versus Conventional Eyedrops

NCT04217785 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-09-21

No results posted yet for this study

Summary

Dry eye disease (DED) is a chronic ocular surface disease and the prevalence of DED has been reported as high as 50%. Recently, The international Dry Eyes Workshop II (DEWS II) defines dry eye as a "multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles". A study done by Yoon et al. on 31 patients with severe DED concluded that UCS eye drops are effective and safe in treating severe DED. Studies found that EGF, TGF-β, VEGF and vitamin A levels were significantly higher in UCS than peripheral blood serum(PBS) whereas IGF content was significantly higher in PBS than in CBS. Yoon et al. then conducted another study whereby he compared UCS to AS in treating both Sjögren syndrome and non- Sjögren syndrome patients with severe dry eyes. They concluded that UCS eye drops were more effective in decreasing symptoms and keratoepitheliopathy in severe dry eye syndrome and increasing goblet cell density in Sjögren syndrome compared with AS drops. Despite proven more effective in treating DED, serum eye drops are not yet widely manufactured due to a few reasons. This study is chosen because

1. Not many previous clinical trials done related to UCS eye drops.
2. There were only two clinical trials done before to compare the use of UCS eye drops versus conventional AT eye drops on Hansen's disease and acute ocular chemical burn injury population.
3. To apply the newer technology of Keratograph® 5M in DED assessment.
4. To initiate a proper standard operating procedure for production as well as delivery of serum eye drops which allowing out-patient treatment with serum eye drops possible.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Optive, Ophthalmic Solution

6 drops per day, for 8 weeks

BIOLOGICAL

Umbilical Cord Serum eye drops

UCS eye drops (6 drops per day, for 8 weeks)

DRUG

Genteal lubricant gel

Genteal lubricant gel (2 drops per day, for 8 weeks)

Sponsors & Collaborators

  • National University of Malaysia

    lead OTHER

Principal Investigators

  • Wan Haslina Wan Abdul Halim, M.D(UKM) · National University of Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2020-12-31
Completion
2021-05-31

Countries

  • Malaysia

Study Locations

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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 NCT04217785 on ClinicalTrials.gov