UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016060 |
|---|---|
| Receipt number | R000018646 |
| 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) |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2017/04/17 13:05:23 |
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Basic information
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
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
| 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
m-abe111007@hotmail.co.jp
Public contact
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
m-abe111007@hotmail.co.jp
Sponsor or person
Institute
Miyake Eye Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018646
