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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014536
Receipt No. 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

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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
Last 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
Email fwiw1193@mb.infoweb.ne.jp

Public contact
1st 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
Email fwiw1193@mb.infoweb.ne.jp

Sponsor
Institute Dry eye society
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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