UMIN-CTR Clinical Trial

Public title

The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery
(multicenter randomized clinical trial)

Acronym

The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery

Scientific Title

The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery
(multicenter randomized clinical trial)

Scientific Title:Acronym

The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery

Region

Japan

Condition

Dry eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness of 3% Diquafosol Sodium ophthalmic solution for dry eye after age-related cataract surgery (confine to phacoemulsification and aspiration) in comparison with artificial tears in multicenter randomized clinical trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The incidence rate of dry eye after cataract surgery.
Tear film breakup time (BUT).
Corneal and conjunctival staining score.
Subjective symptoms (12 items).
Adverse event and side effect.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Diquafosol Sodium ophthalmic solution 3%

Interventions/Control_2

Artificial tear MYTEAR ophthalmic solution

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

To have a plan to be given an age-related cataract surgery (confine to phacoemulsification and aspiration, any incision).
Patients who are diagnosed as definite or probable dry eye by Dry Eye Diagnostic Criteria (study eye).
Corneal and conjunctival staining is 1 or more than 1 point(study eye)

Key exclusion criteria

Patients who have allergic conjunctivitis and have possibilities to get worse during study phase.
Patients who have glaucoma and uveitis requiring treatment. (study eye)
Histories of Lasik, blepharoplasty, ocular injury or corneal transplants. (study eye)
Patients who have diabetic retinopathy. (study eye)
History of allogeneic heamatopoietic stem cell transplantation.
Known allergy to any drug to be used during study phase.
Patients who had a continued use of eye drops for dry eye within 2 weeks before this study. (study eye)
Patients who had a punctal plug (study eye)
Plans to use a prohibited concomitant drug during study phase. (study eye)
Plans to receive prohibited concurrent therapy during study phase. (study eye)
Those who need to wear contact lenses during study phase. (study eye)
Cannot make the specified hospital visits.
The investigator/subinvestigator has judged that the patient is ineligible as study subject.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Kensaku Miyake

Organization

Miyake Eye Hospital

Division name

No

Zip code

Address

3-15-68 Osone, Kitaku, Nagoyashi, Aichi

TEL

052-915-8001

Email

m-abe111007@hotmail.co.jp

Name of contact person

1st name
Middle name
Last name	Kensaku Miyake

Organization

Miyake Eye Hospital

Division name

No

Zip code

Address

3-15-68 Osone, Kitaku, Nagoyashi, Aichi

TEL

052-915-8001

Homepage URL

Email

m-abe111007@hotmail.co.jp

Institute

Miyake Eye Hospital

Institute

Department

Personal name

Organization

Santen pharmaceutical CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人青森眼科　伊藤眼科クリニック（青森県）
医療法人社団平成会　平成眼科病院（宮城県）
医療法人社団 さくら有鄰堂　板橋眼科病院（宮城県）
医療法人社団浩陽会　石川眼科医院（静岡県）
医療法人湘山会　眼科三宅病院（愛知県）
社会医療法人きつこう会　多根記念眼科病院（大阪府）
医療法人眼科康誠会　井上眼科（岡山県）
医療法人節和会　三好眼科（広島県）
医療法人仁光会　日谷眼科（広島県）
医療法人　藤田眼科（徳島県）
医療法人朔夏会　さっか眼科医院（福岡県）
医療法人社団研英会　林眼科病院（福岡県）

Date of disclosure of the study information

2015

Year

01

Month

13

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.dovepress.com/article_31918.t67473166

Number of participants that the trial has enrolled

Results

Subjects were 433 eyes of 433 patients undergoing cataract surgery with intraocular lens implantation. Dry eye examination of tear breakup time (BUT), corneal and conjunctival fluorescein staining scores, total subjective symptom score (12 symptoms), and Schirmer I test were conducted before surgery and 4 weeks after surgery At 4 weeks after surgery, tear breakup time (BUT) was shortened significantly (P=0.036) than before surgery, corneal and conjunctival fluorescein staining score increased significantly (P=0.012). But total subjective symptom score (12 symptoms) was significantly improved (P < 0.001). The majority of postoperative dry eye was shortened BUT type (53.1%). The dry eye prevalence after surgery decreased (55.7%) compared with before surgery (69.7%). Females and the patient with dry eye symptoms before surgery had significant risk factors for postoperative dry eye.
In a randomized study for postoperative dry eye, 154 eyes of 154 patients diagnosed with dry eye postoperatively were applied either 3% Diquafosol Sodium ophthalmic solution (DQS) or artificial tears (AT) six times daily for 4 weeks. BUT after 4 weeks instillation was significantly prolonged in the DQS group (P=0.015), but not in the AT group. Fluorescein staining score was significantly improved in both groups (P<0.001). Total subjective symptom score was significantly decreased in the AT group (P<0.001), but not in the DQS group.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

11

Month

25

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

26

Day

Last modified on

2017

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018646