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

C

Chonnam National University

Status

Completed

Conditions

Dry Eye Syndrome

Treatments

Drug: Autologous serum eyedrops
Drug: Umbilical cord serum eyedrops

Study type

Interventional

Funder types

Other

Identifiers

NCT00442273
UCS-0001

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

20 to 61 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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