UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029333 |
|---|---|
| Receipt number | R000033506 |
| Scientific Title | The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery |
| Date of disclosure of the study information | 2017/10/02 |
| Last modified on | 2023/06/28 10:57:46 |
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Basic information
Public title
The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Acronym
The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Scientific Title
The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Scientific Title:Acronym
The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the change of dry eye findings and refraction data
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dry eye examination results, corneal curvature radius, refraction data and adverse event
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diquafosol 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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
To have a plan to be given a cataract surgery.
Key exclusion criteria
Being on dry eye medication.
Using contact lens.
Having an infection eye disease.
Having a complication of an eye disease which might have an influence on evaluation of this study.
Having a history of an allergic reaction to the ingredients used in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masayo |
| Middle name | |
| Last name | Hashimoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs group, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Yamada |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs group, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9604
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board of Human Rights and Ethics for Clinical Studies Ethics Review Committee
Address
13-2 Ichibancho, Chiyoda-ku, Tokyo
Tel
03-5213-0028
info@hurecs.org
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/11/3/710/htm
Number of participants that the trial has enrolled
69
Results
Refer to paper
Results date posted
| 2023 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 01 | Month | 28 | Day |
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Efficacy evaluation of ophthalmic solutions was not performed due to insufficient number of cases included.
Adverse events
The following adverse events were observed in this study.
Influenza
Heaviness of the right upper eyelid
Corneal edema
Foreign body sensation in the eye
Eye discharge
Increased nasal discharge
Outcome measures
Dry eye examination results, corneal curvature radius, refraction data and adverse event
Plan to share IPD
The data presented in this study are available on request from the corresponding author.
IPD sharing Plan description
The data presented in this study are available on request from the corresponding author.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2007 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033506
