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NCT00442273 Clinical Trial

Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

Official title:
Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00442273
Other study ID # UCS-0001
Secondary ID
Status Completed
Phase N/A
First received February 28, 2007
Last updated February 28, 2007

Study information
Verified date February 2007
Source Chonnam National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome.

Description:

Ninety-two eyes of 48 patients with severe dry eye syndrome (34 eyes of 17 patients with Sjögren’s syndrome and 58 eyes of 31 patients with non-Sjögren’s syndrome) were treated with either 20% autologous serum (41 eyes of 21 patients) or umbilical cord serum eyedrops (51 eyes of 27 patients). Symptom scoring, corneal sensitivity test, tear film break-up time (BUT), Schirmer test, tear clearance rate (TCR), corneal fluorescein staining, and conjunctival impression cytology were performed before and 1 month and 2 months after treatment.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 20 Years to 61 Years
Eligibility Inclusion Criteria:

- Patients with severe dry eye syndrome who were refractory to conventional treatments and had symptoms of dry eye for more than 3 months

- Low tear film break-up time (BUT, < 5 sec)

- Low Schirmer test (5 mm)

- Positive fluorescein or rose bengal vital staining (= 3)

Exclusion Criteria:

- Active ocular infection or inflammation not associated with dry eye

- Contact lens wear

- Ocular allergy

- Ocular surgery within the recent 3 months

- Lid or lash abnormalities

- Pregnant or lactating women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Umbilical cord serum eyedrops

• Autologous serum eyedrops

Locations
Country Name City State
Korea, Republic of Chonnam national university hospital Gwangju

Sponsors (1)
Lead Sponsor Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

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