Condition category
Eye Diseases
Date applied
04/10/2020
Date assigned
13/11/2020
Last edited
19/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cataracts are when the lens of your eye, a small transparent disc, develops cloudy patches. Cataract surgery involves replacing the cloudy lens inside the eye with an artificial one. The Meibomian glands along the rims of the eyelid produce meibum, an oily substance that prevents evaporation of the eye's tear film. Meibomian gland dysfunction (MGD) often occurs after cataract surgery. Diquafosol sodium eye solution is a new treatment for MGD and dry eye syndrome after cataract surgery. One of the usual treatments for post-cataract surgery is sodium hyaluronate eye drops. The aim of this study is to find out whether diquafosol sodium eye drops improve MGD dysfunction and dry eye syndrome after cataract surgery in comparison with sodium hyaluronate eye drops.

Who can participate?
Adult cataract patients with normal lid position and closure and not suffering from any eye diseases

What does the study involve?
Participants will be randomly allocated to use diquafosol sodium or sodium hyaluronate eye drops for 4 months following cataract surgery. Eye assessments are performed at each visit before and after surgery.

What are the possible benefits and risks of participating?
There may be no risks or benefits for the participants. The eye drops are commercially available and have proven clinical safety.

Where is the study run from?
Pusan National University School of Medicine (South Korea)

When is the study starting and how long is it expected to run for?
January 2019 to December 2020

Who is funding the study?
Pusan National University Yangsan Hospital (South Korea)

Who is the main contact?
Dr Sangyoon Kim
ksy9404@naver.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sangyoon Kim

ORCID ID

Contact details

Pusan National University School of Medicine
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea
South
+82 (0)55 360 1447
ksy9404@naver.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Efficacy of 3% diquafosol sodium on the lipid layer and meibomian gland after cataract surgery: a randomized, double-masked study

Acronym

Study hypothesis

3% diquafosol sodium might improve meibomian gland (MGD) dysfunction and dry eye syndrome in comparison with 0.1% sodium hyaluronate after cataract surgery.

Ethics approval

Approved 20/01/2020, Pusan National University Yangsan Hospital Institutional Review Board (#20 Geumo-ro, Mulgeum-eup, Yangsan 50612, South Korea; +82 (0)55 360 3854; pnuyhirb@gmail.com), ref: 05-2019-049

Study design

Prospective randomized double-masked comparative clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Dry eye syndrome, meibomian gland dysfunction

Intervention

Eligible patients are randomized using the random number method into two treatment groups. The first group will use 3% diquafosol sodium ophthalmic solution (Diquas-s®, Mitsubishi Tanabe Pharma Inc., Osaka, Japan) six times daily over 4 months following cataract surgery. The second group receive standard postoperative treatment with 0.1% sodium hyaluronate (HyalQ, Ildong Pharmaceutical Inc., Seoul, Korea).

Intervention type

Drug

Phase

Not Applicable

Drug names

3% diquas sodium ophthalmic solution(Diquas-s®, Mitsubishi Tanabe Pharma Inc., Osaka, Japan); 0.1% sodium hyaluronate (HyalQ, Ildong Pharmaceutical Inc., Seoul, Korea)

Primary outcome measure

Measured at baseline and 4 months:
1. Ocular surface status parameters:
1.1. Lipid layer thickness (LLT) measured using an interferometer
1.2. Schirmer’s type I test using COLOR BAR by Eagle Vision Inc.
1.3. Tear breakup time (TBUT) measured by an ophthalmologist
2. Patients’ symptoms measured using Ocular Surface Disease Index (OSDI) questionnaire
3. Meibomian gland dysfunction assessed using Meiboscores with the LipiView® interferometer

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/01/2019

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Adult cataract patients with normal lid position and closure and not suffering from any ocular diseases

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Total final enrolment

60

Participant exclusion criteria

1. Patients who had used topical anti-inflammatory, antibiotic, or other medication during the previous 90 days before surgery
2. Eyes with a history of trauma, ocular surgery, laser or systemic treatment known to affect tear secretion, autoimmune disease, current use of contact lenses, and/or history of slit-lamp evidence of eye surface disorders

Recruitment start date

11/04/2019

Recruitment end date

18/02/2020

Locations

Countries of recruitment

Korea, South

Trial participating centre

Pusan National University School of Medicine
Department of Ophthalmology 20-Geumo-ro Mulgeum-eup
Yangsan
50612
Korea, South

Sponsor information

Organisation

Pusan National University Yangsan Hospital

Sponsor details

20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea
South
+82 (0)55 360 1447
jiel75@hanmail.net

Sponsor type

Hospital/treatment centre

Website

http://www.pnuyh.or.kr/pnuh/main/main.do?rbsIdx=1

Funders

Funder type

Hospital/treatment centre

Funder name

Pusan National University Yangsan Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

20/01/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/10/2020: Trial's existence confirmed by Pusan National University Yangsan Hospital Institutional Review Board.