NCT02291731

Brief Summary

To evaluate the clinical effect of combination of topical 20% (v/v) autologous serum eye drops and a silicone-hydrogel contact lens (CLs) in the treatment of recalcitrant persistent epithelial defects (PEDs) and the recurrence rate of epithelial breakdown with or without continued use of autologous serum eye drops.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

November 7, 2014

Last Update Submit

September 16, 2015

Conditions

Corneal Diseases

Keywords

Autologous serum eye dropsSilicone-hydrogel contact lensPersistent epithelial defectsCorneal epithelial defects

Outcome Measures

Primary Outcomes (1)

  • epithelial defect healing rate

    2-week

Secondary Outcomes (1)

  • epithelial defect recurrence rate

    3-month

Study Arms (1)

Continuous use of autologous serum

EXPERIMENTAL

with continuous use of topical autologous serum for an additional 2 weeks after total re-epithelialization.

Drug: Continuous use of topical autologous serum

Interventions

Continuous use of topical autologous serumDRUG

Silicone-hydrogel SCLs combined with 20% (v/v) autologous serum eye drops were used until complete re-epithelialization. SCLs were removed after total re-epithelialization and patients were subsequently randomized divided into two groups: (1) with and (2) without continuous use of topical autologous serum for an additional 2 weeks after SCLs removal.

Also known as: autologous serum eye drops
Continuous use of autologous serum

Eligibility Criteria

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

You may qualify if:

  • Patients with PEDs for more than 1-month following conventional treatment, visiting E-Da Hospital, Kaohsiung, Taiwan.

You may not qualify if:

  • Patients had dry eye syndrome with a Schirmer test (\<10 mm in 5 minutes) or lid abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-DA hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Yan-Ming Chen, M.D.

    Department of Ophthalmology, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2014

First Posted

November 14, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

TW(1)