Condition category
Eye Diseases
Date applied
03/05/2014
Date assigned
27/05/2014
Last edited
27/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dry eye disease occurs when the eyes do not make enough tears or the tears evaporate too quickly, leading to the eyes drying out and becoming inflamed (red and swollen) and irritated. Our goal is to compare the effectiveness of preservative-free sodium hyaluronate and diquafosol combination treatment, treatment with diquafosol alone and preserved sodium hyaluronate alone in treating dry eye disease.

Who can participate?
Patients aged over 21 with dry eye disease can take part in this study.

What does the study involve?,
Patients were randomly allocated to one of three groups: Group 1 (50 patients) was treated with preserved sodium hyaluronate , Group 2 (50 patients) with diquafosol, and Group 3 (50 patients) with diquafosol and preservative-free sodium hyaluronate eyedrops for 3 months. We will perform various tests and laboratory measurements at the start of the study and 1, 2, and 3 months after the treatment.

What are the possible benefits and risks of participating?
Treatment of dry eye syndrome will relieve dry eye symptoms. There are no risks involved in this study.

Where is the study run from?
Bucheon St. Mary's Hospital (South Korea).

When is the study starting and how long is it expected to run for?
Recruitment started in early 2013. Participants were enrolled on the study for a period of 6 months between May 2013 and December 2013.

Who is funding the study?
National Research Foundation of Korea (NRF) (South Korea).

Who is the main contact?
Professor Eun Chul Kim
eunchol@hanmail.net

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eun Chul Kim

ORCID ID

Contact details

Department of Ophthalmology
Bucheon St Mary's Hospital
327 Sosa-ro
Wonmi-gu
Gyeonggi-do
Bucheon
420-717
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Additive effect of preservative-free sodium hyaluronate 0.1% in treatment of dry eye syndrome with diquafosol 3% eyedrops

Acronym

Study hypothesis

Preservative-free lubricants can augment the treatment effect of diquafosol by enhancing ocular surface stabilization.

Ethics approval

Institutional review board regulations (IRB) of Bucheon St Mary's Hospital

Study design

Prospective randomized controlled parallel-group study, 14/02/2011, NO: HC11RIM10003

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dry eye syndrome

Intervention

Participants were randomized to one of the following three groups:
Group 1 (50 patients, 50 eyes) were treated with preserved sodium hyaluronate 0.1% eyedrops (Lacure, Samil, Seoul, Korea) (four times a day) in the 1, 2 and 3 months
Group 2 (50 patients, 50 eyes) were treated with diquafosol 3% eyedrops (four times a day) in the 1, 2 and 3 months
Group 3 (50 patients ,50 eyes) were treated with diquafosol 3% and preservative-free sodium hyaluronate 0.1% eyedrops (Tearin free, DHP Korea, Seoul, Korea) (four times a day) in the 1, 2 and 3 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Ocular surface disease index (OSDI) scoring
2. tBUT
3. Schirmer I test (without anesthesia)

All outcomes were measured before treatment and at 1, 2 and 3 months after the start of treatment.

Secondary outcome measures

1. Corneal fluorescein staining
2. Conjunctival impression cytology

All outcomes were measured before treatment and at 1, 2 and 3 months after the start of treatment.

Overall trial start date

01/05/2013

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Low tear film break-up time (tBUT) (<5 seconds)
2. Low Schirmer I score (10 mm/5 minutes without anesthesia)
3. Mild corneal punctate fluorescein staining (staining score of ≥1) in either eye (scale 0 ~ 3)
4. At least 21 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 patients

Participant exclusion criteria

1. History of ocular injury, infection, non-dry eye ocular inflammation, trauma, or surgery within the prior 6 months
2. Presence of uncontrolled systemic disease

Recruitment start date

01/05/2013

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Ophthalmology
Bucheon
420-717
Korea, South

Sponsor information

Organisation

Bucheon St Mary's Hospital (South Korea)

Sponsor details

Department of Ophthalmology
327 Sosa-ro
Wonmi-gu
Gyeonggi-do
Bucheon
420-717
Korea
South

Sponsor type

Hospital/treatment centre

Website

http://www.cmcbucheon.or.kr/

Funders

Funder type

Research organisation

Funder name

National Research Foundation of Korea (NRF) (South Korea)

Alternative name(s)

NRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Korea, South

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes