UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002194 |
|---|---|
| Receipt number | R000002680 |
| Scientific Title | Autologous serum eye drops with added hyaluronic acid in the conjunctival sac: a study of the residual time |
| Date of disclosure of the study information | 2009/07/21 |
| Last modified on | 2014/01/23 23:41:47 |
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Basic information
Public title
Autologous serum eye drops with added hyaluronic acid in the conjunctival sac: a study of the residual time
Acronym
A study of autologous serum eye drops with added hyaluronic acid
Scientific Title
Autologous serum eye drops with added hyaluronic acid in the conjunctival sac: a study of the residual time
Scientific Title:Acronym
A study of autologous serum eye drops with added hyaluronic acid
Region
| Japan |
Condition
Condition
keratoconjunctival dysfunction,severe dry eye,late-onset bleb leak after trabeculectomy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of hyaluronic acid to prolong the residual time of autologous serum eye drops in the conjunctival sac.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Albumin concentration in the conjunctival sac 10 min.,30min.,1hr and 3hrs.after administration of autologous serum eye drops added hyaluronic acid
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
apply 10 microliter autologous serum eye drops added hyaluronic acid(autologous serum50%,hyaleinmini0.3%,33%, cravit16.7%),48hrs,apply 10 microliter autologous serum eye drops added saline(autologous serum50%,saline33%,cravit16.7%)
Interventions/Control_2
apply 10 microliter autologous serum eye drops added saline(autologous serum50%,saline33%,cravit16.7%),48hrs,apply 10 microliter autologous serum eye drops added hyaluronic acid(autologous serum50%,hyaleinmini0.3,33%,cravit16.7%)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
persons without severe keratoconjunctival dysfunction
Key exclusion criteria
paient with severe keratoconjunctival dysfunction
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideto Sagara |
Organization
Marui Eye Clinic
Division name
Director
Zip code
Address
1-83-2, Honjinmae Haramachi-ku, Minamisouma, Fukushima 975-0062, Japan.
TEL
0244-25-7488
hide1234@ruby.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideto sagara |
Organization
Marui Eye Clinic
Division name
Director
Zip code
Address
1-83-3, Honjinmae Haramachi-ku, Minamisoma City, Fukushima Prefecture 975-0062, Japan
TEL
0244-25-7488
Homepage URL
hide1234@ruby.ocn.ne.jp
Sponsor or person
Institute
Marui Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Marui 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
| 2009 | Year | 07 | Month | 21 | 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
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 14 | Day |
Last modified on
| 2014 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002680
