The effect of 3% diquafosol sodium eye drops in patients after cataract surgery

ISRCTN ISRCTN18755487
DOI https://doi.org/10.1186/ISRCTN18755487
Submission date
04/10/2020
Registration date
13/11/2020
Last edited
29/04/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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. Postoperative Dry Eye Syndrome (DES) often occurs after cataract surgery. Diquafosol sodium eye solution is a new treatment for 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 15 weeks following cataract surgery. Eye assessments are performed at each visit 1week before and 3, 7, 15 weeks 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 2020 to November 2020

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

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

Contact information

Dr Sangyoon Kim
Scientific

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

Phone +82 (0)55 360 1447
Email ksy9404@naver.com

Study information

Study designProspective, randomized double-masked comparative clinical trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleEfficacy of 3% diquafosol sodium on tear breakup time (TBUT), Schirmer’s I test score, ocular surface disease index (OSDI) score, lipid layer thickness (LLT) after cataract surgery: a randomized, double-masked study
Study objectivesCurrent study hypothesis as of 28/01/2021:
3% diquafosol sodium might improve ocular surface status and dry eye syndrome in comparison with 0.1% sodium hyaluronate after cataract surgery.

Previous 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(s)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
Health condition(s) or problem(s) studiedDry eye syndrome, meibomian gland dysfunction
InterventionCurrent interventions as of 28/01/2021:
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 15 weeks following cataract surgery. The second group receive standard postoperative treatment with 0.1% sodium hyaluronate (HyalQ, Ildong Pharmaceutical Inc., Seoul, Korea).

Previous interventions:
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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)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 measureCurrent primary outcome measure as of 28/01/2021:
Measured at baseline (1 week before cataract surgery) and 3, 7, 15 weeks after cataract surgery:
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

Previous 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 measuresThere are no secondary outcome measures
Overall study start date01/01/2020
Completion date09/11/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Total final enrolment60
Key inclusion criteriaCurrent inclusion criteria as of 28/01/2021:
In order to be eligible for participation in this study, the subject had to:
1. Be male or female, aged 19 years or older
2. Have a tear breakup time (TBUT) of 10 seconds or more
3. Have a Schirmer’s I test result of 10 mm or more
4. Have not used diquafosol-based eye drops, artificial tear drops, steroid eye drops, or antibiotic eye drops within 3 months before participation
5. Show normal blinking during a slit lamp exam
6. Voluntarily agree to participate in this study

Previous inclusion criteria:
Adult cataract patients with normal lid position and closure and not suffering from any ocular diseases
Key exclusion criteriaCurrent exclusion criteria as of 28/01/2021:
The subject is excluded from the study if the subject either:
1. Has Sjögren's syndrome
2. Has severe blepharitis
3. Had ocular surgery or laser eye surgery
4. Has severe ocular inflammation/infection
5. Is using eye drop treatment for dry eyes, such as glaucoma or allergies
6. Shows sensitivity to the study drugs
7. Is considered to be ineligible for participation owing to reasons other than the aforementioned exclusion criteria based on the judgment of the principal researcher

Previous 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
Date of first enrolment20/02/2020
Date of final enrolment18/07/2020

Locations

Countries of recruitment

  • Korea, South

Study participating centre

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

Sponsor information

Pusan National University Yangsan Hospital
Hospital/treatment centre

20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea, South

Phone +82 (0)55 360 1447
Email jiel75@hanmail.net
Website http://www.pnuyh.or.kr/pnuh/main/main.do?rbsIdx=1
ROR logo "ROR" https://ror.org/04kgg1090

Funders

Funder type

Hospital/treatment centre

Pusan National University Yangsan Hospital

No information available

Results and Publications

Intention to publish date20/04/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 27/04/2021 29/04/2021 Yes No

Editorial Notes

29/04/2021: Publication reference added.
02/02/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/01/2019 to 01/01/2020.
2. The recruitment start date was changed from 11/04/2019 to 20/02/2020.
3. The recruitment end date was changed from 18/02/2020 to 18/07/2020.
4. The overall trial start date was changed from 31/12/2020 to 09/11/2020.
5. The intention to publish date was changed from 20/01/2021 to 20/04/2021.
28/01/2021: The following changes were made to the trial record:
1. The scientific title was changed from 'Efficacy of 3% diquafosol sodium on the lipid layer and meibomian gland after cataract surgery: a randomized, double-masked study' to 'Efficacy of 3% diquafosol sodium on tear breakup time (TBUT), Schirmer’s I test score, ocular surface disease index (OSDI) score, lipid layer thickness (LLT) after cataract surgery: a
randomized, double-masked study'.
2. The study hypothesis, interventions, primary outcome measures, and inclusion/exclusion criteria were updated.
3. The plain English summary was updated to reflect these changes.
19/10/2020: Trial's existence confirmed by Pusan National University Yangsan Hospital Institutional Review Board.