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
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
Scientific
Pusan National University School of Medicine
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea, South
| Phone | +82 (0)55 360 1447 |
|---|---|
| ksy9404@naver.com |
Study information
| Study design | Prospective, randomized double-masked comparative clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | 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 |
| Study objectives | Current 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) studied | Dry eye syndrome, meibomian gland dysfunction |
| Intervention | Current 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 type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not 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 measure | Current 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 measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2020 |
| Completion date | 09/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 60 |
| Key inclusion criteria | Current 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 criteria | Current 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 enrolment | 20/02/2020 |
| Date of final enrolment | 18/07/2020 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
20-Geumo-ro Mulgeum-eup
Yangsan
50612
Korea, South
Sponsor information
Hospital/treatment centre
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea, South
| Phone | +82 (0)55 360 1447 |
|---|---|
| jiel75@hanmail.net | |
| Website | http://www.pnuyh.or.kr/pnuh/main/main.do?rbsIdx=1 |
"ROR" |
https://ror.org/04kgg1090 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 20/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The 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.
