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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012111
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email ikuko@tka.att.ne.jp

Sponsor
Institute Minamiaoyama Eye Clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014158


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