NCT01016158

Brief Summary

In the present study, the investigators investigated the efficacy of umbilical cord serum eye drops for the treatment of patients with recurrent corneal erosions. Group A were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears, and group B were treated with artificial tears only. Ophthalmic examinations including visual acuity measurement and slit lamp biomicroscopy were performed before and every month after treatment. Recurrence was defined as the presence of clinical symptoms accompanied by epithelial defects in the cornea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

Enrollment Period

3 years

First QC Date

November 18, 2009

Last Update Submit

November 18, 2009

Conditions

Recurrent Corneal Erosion

Keywords

Umbilical cord serumRecurrent corneal erosion

Study Arms (1)

umbilical cord serum eyedrops

EXPERIMENTAL

patients with recurrent corneal erosions were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears

Drug: Umbilical cord serum eyedrops

Interventions

Umbilical cord serum eyedropsDRUG

20% umbilical cord serum eye drops 3 to 4 times a day

umbilical cord serum eyedrops

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with recurrent corneal erosions

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hospital

Gwangju, South Korea

Location

Related Publications (3)

  • Yoon KC, Im SK, Park YG, Jung YD, Yang SY, Choi J. Application of umbilical cord serum eyedrops for the treatment of dry eye syndrome. Cornea. 2006 Apr;25(3):268-72. doi: 10.1097/01.ico.0000183484.85636.b6.

    PMID: 16633024RESULT

  • del Castillo JM, de la Casa JM, Sardina RC, Fernandez RM, Feijoo JG, Gomez AC, Rodero MM, Sanchez JG. Treatment of recurrent corneal erosions using autologous serum. Cornea. 2002 Nov;21(8):781-3. doi: 10.1097/00003226-200211000-00010.

    PMID: 12410036RESULT

  • Yoon KC, You IC, Im SK, Jeong TS, Park YG, Choi J. Application of umbilical cord serum eyedrops for the treatment of neurotrophic keratitis. Ophthalmology. 2007 Sep;114(9):1637-42. doi: 10.1016/j.ophtha.2006.12.014. Epub 2007 Mar 26.

    PMID: 17382396RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 19, 2009

Study Start

April 1, 2006

Primary Completion

April 1, 2009

Study Completion

October 1, 2009

Last Updated

November 19, 2009

Record last verified: 2009-11

Locations

KR(1)