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
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
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