UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014536 |
|---|---|
| Receipt number | R000016907 |
| Scientific Title | The influence of tear film stability on visual function, accommodative microfluctuations and scattering |
| Date of disclosure of the study information | 2014/07/20 |
| Last modified on | 2018/06/23 10:26:13 |
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Basic information
Public title
The influence of tear film stability on visual function, accommodative microfluctuations and scattering
Acronym
The influence of tear film stability on visual function, accommodative microfluctuations and scattering
Scientific Title
The influence of tear film stability on visual function, accommodative microfluctuations and scattering
Scientific Title:Acronym
The influence of tear film stability on visual function, accommodative microfluctuations and scattering
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Part 1
To investigate the difference of visual function, accommodative microfluctuations and scattering in patients with short tear breakup time dry eye and non-dry eye
Part2-1
To investigate the effects of diquafosol ophthalmic solution on visual function, accommodative microfluctuations and scattering in patients with short tear breakup time dry eye compared to artificial tear
Part2-2
To investigate the effects of blue-light cut lens on visual function, accommodative microfluctuations and scattering in patients with short tear breakup time dry eye compared to control lens
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Part1
Visual function
Accommodative microfluctuations
Scattering
Part2-1
Visual function
Accommodative microfluctuations
Scattering
Subjective symptoms(only eye fatigue)
Part2-2
Visual function
Accommodative microfluctuations
Scattering
Subjective symptoms(only eye fatigue)
Key secondary outcomes
Part1
Subjective symptoms
Dry eye inspection item
Part2-1
Subjective symptoms(except eye fatigue)
Dry eye inspection item
Part2-2
Subjective symptoms(except eye fatigue)
Dry eye inspection item
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 not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Part2-1
DIQUAS ophthalmic solution3%
Part2-2
Blue-light cut lens
Interventions/Control_2
Part2-1
Soft Santear
Part2-2
Control lens
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
| 25 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Part1
Short tear film breakup time(BUT)-type Dry Eye group
;Patients with dry eye subjective symptoms score [3:absolutely yes]or[2:yes]
;Patients who usually don't wear glasses and contact lens
;25-45 years old
;Patients with no history of eye disease(except dry eye) within 4 weeks
;Patients with no history of eye treatment within 4 weeks
;Patients with no history of ocular surgery(including laser therapy)within 24 weeks
;Patients who don't have lacrimal punctual atresia
Not dry eye group
;Patients with no dry eye subjective symptoms score [3:absolutely yes]or [2:yes]
;25-45 years old
;Patients with no history of eye disease within 4 weeks
;Patients with no history of eye treatment within 4 weeks
;Patients with no history of ocular surgery(including laser therapy)within 24 weeks
;Patients who don't occluding punctum
Part2-1(in addition to Part1)
;Corneo-conjunctival staining score < 3
;Tear film breakup time <= 5 seconds
;Schirmer test(I) > 5mm
Part2-2(in addition to Part1)
;Corneo-conjunctival staining score < 3
;Tear film breakup time <= 5 seconds
;Schirmer test(I)>5mm
Key exclusion criteria
Part1
;any eye disease that may influence of the assessment of the study
;any conditions that may influence of the assessment of the study
Part2-1;any eye disease that may influence of the assessment of the study
;any conditions that may influence of the assessment of the study
Part2-2
;any eye disease that may influence of the assessment of the study
;any conditions that may influence of the assessment of the study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minako Kaido |
Organization
Keio university hospital
Division name
Department of ophthalmology
Zip code
Address
35 Shinanomatchi, Shinjuku, Tokyo
TEL
03-3353-1211
fwiw1193@mb.infoweb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minako Kaido |
Organization
Keio university hospital
Division name
Department of ophthalmology
Zip code
Address
35 Shinanomatchi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
fwiw1193@mb.infoweb.ne.jp
Sponsor or person
Institute
Dry eye society
Institute
Department
Personal name
Funding Source
Organization
Santen pharmaceutical company
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
医療法人社団信濃会 信濃坂クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28886090
Number of participants that the trial has enrolled
Results
Part 1
Mean blink frequency and High frequency component 1 values in accommodative micro-fluctuation measurements were significantly higher in the dry eye group than they were in the non-dry eye group.
Part 2
Diquafisol ophthalmic solution (DQS) significantly improved tear break up time (BUT) and tear meniscus height (TMH) scores, while artificial tears (AT) significantly improved tear BUT but not TMH score. Mean perception of pain and dry eye symptom scores were lower after medication use in the DQS and AT groups. However, perception of touch did not significantly change in either group. A positive correlation was observed between the improvement degrees of perception of pain and dry eye symptoms in the overall study subjects.
https://www.ncbi.nlm.nih.gov/pubmed/29671255
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 | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 11 | Day |
Last modified on
| 2018 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016907
