UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010241 |
|---|---|
| Receipt number | R000011988 |
| Scientific Title | Changes in Intraocular Scattering after Instillation of Diquafosol Ophthalmic Solution in Patients with Short Tear Breakup Time Type of Dry Ey |
| Date of disclosure of the study information | 2013/03/14 |
| Last modified on | 2013/03/14 08:06:50 |
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Basic information
Public title
Changes in Intraocular Scattering after Instillation of Diquafosol Ophthalmic Solution in Patients with Short Tear Breakup Time Type of Dry Ey
Acronym
Intraocular scattering after diquafosol eyedrops in dry eye
Scientific Title
Changes in Intraocular Scattering after Instillation of Diquafosol Ophthalmic Solution in Patients with Short Tear Breakup Time Type of Dry Ey
Scientific Title:Acronym
Intraocular scattering after diquafosol eyedrops in dry eye
Region
| Japan |
Condition
Condition
patients with short tear breakup time (TBUT) dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the changes in intraocular scattering before and after instillation of diquafosol ophthalmic solution in patients with short tear breakup time (TBUT) dry eye.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
objective scattering index (OSI)
Key secondary outcomes
tear breakup time (TBUT)
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
3% diquafosol ophthalmic solution
Interventions/Control_2
Without 3% diquafosol 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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Short TBUT dry eye was diagnosed in patients when the TBUT values were equal to or shorter than 5 seconds, and the subjects had dry eye-related symptoms with no positive fluorescein staining or scores less than 3 points. All subjects were emmetropic or low-myopic with a visual acuity of 20/20 or better.
Key exclusion criteria
Any history of treatment for dry eye, previous ocular surgery, ocular trauma, contact lens use, punctual occlusion or diathermy, or eye disease including active inflammation of the eye, was excluded from the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenaga Kobashi |
Organization
University of Kitasato School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 228-8555, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Kitasato School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
himon@hotmail.co.jp
Sponsor or person
Institute
University of Kitasato School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The authors have no commercial or propriety interest in the product or company described in the current study.
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 03 | Month | 14 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 14 | Day |
Last modified on
| 2013 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011988
