UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012111 |
|---|---|
| Receipt number | R000014158 |
| Scientific Title | Combination therapy with diquafosol tetrasodium and sodium hyaluronate in patients with dry eye after laser in situ keratomileusis. |
| Date of disclosure of the study information | 2013/10/31 |
| Last modified on | 2013/10/23 18:29:30 |
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Basic information
Public title
Combination therapy with diquafosol tetrasodium and sodium hyaluronate in patients with dry eye after laser in situ keratomileusis.
Acronym
Combination therapy with diquafosol tetrasodium and sodium hyaluronate in patients with dry eye after laser in situ keratomileusis.
Scientific Title
Combination therapy with diquafosol tetrasodium and sodium hyaluronate in patients with dry eye after laser in situ keratomileusis.
Scientific Title:Acronym
Combination therapy with diquafosol tetrasodium and sodium hyaluronate in patients with dry eye after laser in situ keratomileusis.
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o evaluate the possible advantages of combination therapy with diquafosol tetrasodium and sodium hyaluronate for dry eye after laser in situ keratomileusis(LASIK).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Dry eye symptoms
Uncorrected visual acuity
Corrected visual acuity
Functional visual acuity
Manifest refraction
Key secondary outcomes
Tear film breakup time
Fluorescein corneal staining
Schirmer test
Corneal sensitivity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sodium hyaluronate ophthalmic solution
Interventions/Control_2
Diquafosol sodium ophthalmic solution
Interventions/Control_3
Combination of sodium hyaluronate ophthalmic solution and diquafosol sodium ophthalmic solution
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) 20 years old or older.
2) female or male.
3) Patients who will undergo LASIK at Minamiaoyama Eye Clinic.
Key exclusion criteria
1) Patients who need to treat other eye disease.
2) Patients who take some medications causing dry eye.
3) Patients who judged to be not suitable by a doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuko Toda |
Organization
Minamiaoyama Eye Clinic
Division name
Ophthalmology
Zip code
Address
3-3-11, Kitaaoyama, Renei Aoyama Building #4, Minato-ku, Tokyo
TEL
03-5772-1440
ikuko@tka.att.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuko Toda |
Organization
Minamiaoyama Eye Clinic
Division name
Ophthalmology
Zip code
Address
3-3-11, Kitaaoyama, Renei Aoyama Building #4, Minato-ku, Tokyo
TEL
03-5772-1440
Homepage URL
ikuko@tka.att.ne.jp
Sponsor or person
Institute
Minamiaoyama Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Minamiaoyama Eye Clinic
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
| 2013 | Year | 10 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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 | 10 | Month | 23 | Day |
Last modified on
| 2013 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014158
