The efficacy of diquafosol eyedrops in dry eye syndrome
| ISRCTN | ISRCTN44290046 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44290046 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/05/2014
- Registration date
- 27/05/2014
- Last edited
- 27/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Ophthalmology
Bucheon St Mary's Hospital
327 Sosa-ro
Wonmi-gu
Gyeonggi-do
Bucheon
420-717
Korea, South
Study information
| Study design | Prospective randomized controlled parallel-group study, 14/02/2011, NO: HC11RIM10003 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Additive effect of preservative-free sodium hyaluronate 0.1% in treatment of dry eye syndrome with diquafosol 3% eyedrops |
| Study objectives | Preservative-free lubricants can augment the treatment effect of diquafosol by enhancing ocular surface stabilization. |
| Ethics approval(s) | Institutional review board regulations (IRB) of Bucheon St Mary's Hospital |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2013 |
| Completion date | 01/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2013 |
| Date of final enrolment | 01/12/2013 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
420-717
Korea, South
Sponsor information
Hospital/treatment centre
Department of Ophthalmology
327 Sosa-ro
Wonmi-gu
Gyeonggi-do
Bucheon
420-717
Korea, South
| Website | http://www.cmcbucheon.or.kr/ |
|---|---|
"ROR" |
https://ror.org/01fpnj063 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 한국연구재단이 창의적 연구와, National Research Foundation (South Korea), NRF
- Location
- Korea, South
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
