UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017667 |
|---|---|
| Receipt number | R000020478 |
| Scientific Title | Effect of eye drops for dry eye, glaucoma and cataract surgery using DEQS (Dry Eye Related Quality of Life Score) |
| Date of disclosure of the study information | 2015/05/25 |
| Last modified on | 2015/05/25 15:36:52 |
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Basic information
Public title
Effect of eye drops for dry eye, glaucoma and cataract surgery using DEQS (Dry Eye Related Quality of Life Score)
Acronym
Effect of eye drops for dry eye, glaucoma and cataract surgery
Scientific Title
Effect of eye drops for dry eye, glaucoma and cataract surgery using DEQS (Dry Eye Related Quality of Life Score)
Scientific Title:Acronym
Effect of eye drops for dry eye, glaucoma and cataract surgery
Region
| Japan |
Condition
Condition
Dry eye, Glaucoma, and Cataract (Cataract surgery)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of eye drops for dry eye, glaucoma, and cataract surgery using DEQS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Clinical assessments of the conjunctival and corneal fluorescein staining scores, tear film breakup times (BUT), Schirmer's tests, DEQS scores, and tear meniscus areas using anterior segment optical coherence tomography
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
The treatment with each ophthalmic solution for dry eye, glaucoma, or cataract surgery is started.
Interventions/Control_2
The treatment with each another ophthalmic solution for dry eye, glaucoma, or cataract surgery is started.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age of 20 years and over
2) Patients who plan to start the treatment with ophthalmic solution for dry eye
3) Patients who plan to start the treatment with ophthalmic solution for glaucoma
4) Patients who plan to start the treatment with ophthalmic solution for cataract surgery
5) Under the description of the study to understand its significance, written consent is obtained from the patients themselves
Key exclusion criteria
1) Patients who are judged inappropriately for principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Kawahara, Tsugiaki Utsunomiya |
Organization
Sapporo Tokushukai Hospital
Division name
Ophthalmology
Zip code
Address
1-1, Oyachihigashi 1chome, Atsubetsu-ku, Sapporo Hokkaido, 004-0041, JAPAN
TEL
011-890-1110
atsusi-k@coral.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Kawahara, Tsugiaki Utsunomiya |
Organization
Sapporo Tokushukai Hospital
Division name
Ophthalmology
Zip code
Address
1-1, Oyachihigashi 1chome, Atsubetsu-ku, Sapporo Hokkaido, 004-0041, JAPAN
TEL
011-890-1110
Homepage URL
atsusi-k@coral.plala.or.jp
Sponsor or person
Institute
Sapporo Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2013 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 25 | Day |
Last modified on
| 2015 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020478
