UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022332 |
|---|---|
| Receipt number | R000025732 |
| Scientific Title | The effect of 3% Diquafosol Sodium ophthalmic solution for High-order aberration on the patient diagnosed as the dry eye after a cataract surgery. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2017/01/20 11:55:59 |
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Basic information
Public title
The effect of 3% Diquafosol Sodium ophthalmic solution for High-order aberration on the patient diagnosed as the dry eye after a cataract surgery.
Acronym
The effect of 3% Diquafosol Sodium ophthalmic solution for High-order aberration on the patient diagnosed as the dry eye after a cataract surgery.
Scientific Title
The effect of 3% Diquafosol Sodium ophthalmic solution for High-order aberration on the patient diagnosed as the dry eye after a cataract surgery.
Scientific Title:Acronym
The effect of 3% Diquafosol Sodium ophthalmic solution for High-order aberration 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
A clinical study carried out in Inoue Eye Clinic for approved dry eye patients after the cataract surgery for the age-related cataract surgery intends for a subject of examination in multicenter randomized clinical trial to evaluate the effectiveness of 3% Diquafosol Sodium ophthalmic solution for the patient who accepted dry eye syndrome after cataract surgery.
Implemented subsequent analysis for contrast with a tear artificially to Examine the influence Diquafosol Sodium ophthalmic solution about High-order aberration that was usually measured as inspection of the medical treatment during the inspection observation period of this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-High-order aberration
-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
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
- Implemented an age-related cataract surgery.
- Patients who are diagnosed as definite
or probable dry eye by Dry Eye
Diagnostic Criteria (study eye) before apply.
- The Corneal and conjunctival
staining was more than 1 point (out of 9 points) before apply.
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.
- Histories of Lasik, blepharoplasty,ocular injury or corneal transplants.
- Patients had a naked eye surgery of ocular trauma within 1 year before this study.
- Patients who have diabetic retinopathy.
- History of allogeneic hematopoietic
stem cell transplantation.
- Patients who had a punctual plug.
- Used a prohibited concurrent drug.
- Received prohibited concurrent therapy.
- Wore contact lenses.
- The investigator/subinvestigator has judged that the patient is ineligible as a subject of the study.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Inoue |
Organization
Inoue Eye Clinic
Division name
No
Zip code
Address
1-14-31 Uno, Tamanoshi, Okayama
TEL
0863-31-1030
inoue@oka.urban.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Inoue |
Organization
Inoue Eye Clinic
Division name
No
Zip code
Address
1-14-31 Uno, Tamanoshi, Okayama
TEL
0863-31-1030
Homepage URL
inoue@oka.urban.ne.jp
Sponsor or person
Institute
Inoue Eye Clinic
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
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
医療法人眼科康誠会 井上眼科（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/articles.php?article_id=30652.
Number of participants that the trial has enrolled
Results
After 4 weeks of instillation, Tear breakup time (BUT) significantly increased compared with pre-instillation values in the diquafosol sodium ophthalmic solution 3% (DQS) group, but not in the artificial tears (AT) group. This increase in BUT in the DQS group was significantly greater than in the AT group. Corneal and conjunctival fluorescein staining scores after instillation significantly improved compared with pre-instillation values in the DQS group. In higher-order aberrations , the cornea aberration changed from an upward curve (a sawtooth pattern) to an almost constant value (a stable pattern) in the DQS group, but not in the AT group. In Fluctuation Index (FI) and stability index (SI), there were no significant changes in either group; however, FI and SI were significantly lower in the DQS group than in the AT 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
| 2016 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 06 | Month | 09 | Day |
Other
Other related information
Study type
-Observational
Recruitment
-The same patient as UMIN 000016060
Measurement item
- High-order aberration
- Tear film breakup time(BUT)
- Corneal and conjunctival staining score
- Subjective symptoms(12 items)
- Adverse event and side effect
Management information
Registered date
| 2016 | Year | 05 | Month | 17 | Day |
Last modified on
| 2017 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025732
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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