UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery (multicenter randomized clinical trial)
Title of the study (Brief title)	The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery
Region	Japan

Condition
Condition	Dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kensaku Miyake
Organization	Miyake Eye Hospital
Division name	No
Address	3-15-68 Osone, Kitaku, Nagoyashi, Aichi
TEL	052-915-8001
Email	m-abe111007@hotmail.co.jp

Public contact
Name of contact person	Kensaku Miyake
Organization	Miyake Eye Hospital
Division name	No
Address	3-15-68 Osone, Kitaku, Nagoyashi, Aichi
TEL	052-915-8001
Homepage URL
Email	m-abe111007@hotmail.co.jp

Sponsor
Institute	Miyake Eye Hospital
Institute
Department

Funding Source
Organization	Santen pharmaceutical CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.dovepress.com/article_31918.t67473166
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.
Other related information

Management information
Registered date	2014 Year 12 Month 26 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018646