UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035991 |
|---|---|
| Receipt number | R000040995 |
| Scientific Title | To compare safety and efficacy of cyclosporine 0.05% and cyclosporine 0.09% eyedrops for dry eye (keratoconjunctivitis). |
| Date of disclosure of the study information | 2019/02/24 |
| Last modified on | 2019/02/24 15:27:34 |
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Basic information
Public title
To compare safety and efficacy of cyclosporine 0.05% and cyclosporine 0.09% eyedrops for dry eye (keratoconjunctivitis).
Acronym
Cyclosporine 0.05% versus 0.09% for dry eye.
Scientific Title
To compare safety and efficacy of cyclosporine 0.05% and cyclosporine 0.09% eyedrops for dry eye (keratoconjunctivitis).
Scientific Title:Acronym
Cyclosporine 0.05% versus 0.09% for dry eye.
Region
| Asia(except Japan) |
Condition
Condition
Dry Eye Syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare safety and efficacy of Cyclosporine 0.05% and cyclosporine 0.09% eye drops for dry eye (keratoconjunctivitis).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change from
baseline in subjective dry eye symptoms score.
Key secondary outcomes
Change from baseline in the Schirmer-1 test values as
a measure of tear production, TBUT as a measure of tear film
stability, and CIC scores (Nelson grade) for cellular morphology
and Goblet cell density.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1 received cyclosporine 0.05% eye drops twice daily for 12 weeks
Interventions/Control_2
Group 2 received cyclosporine 0.09% eye drops twice daily for 12 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects experiencing dry eye symptoms.
Key exclusion criteria
Patients with current ocular infection, history of laser in
situ keratomileusis, allergic conjunctivitis, herpetic eye disease,
diabetes, and liver diseases were excluded. Other exclusion
criteria were pregnant or lactating mothers, HIV, and hepatitis
B and C. Patients who
were allergic to fluorescein were excluded. Systemic
(tetracyclines and corticosteroids) or topical medications (other
than artificial tear supplements) that could affect tear production or
meibomian gland functions were discontinued before intervention.
However, patients were instructed not to use artificial tear
preparations, 2 hours before testing. Computer work was not
allowed during the course of the study as concurrent use of
visual display terminals may independently influence ocular
surface changes.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rahul Bhargava |
Organization
Laser Eye Clinic, Noida
Division name
Ophthalmology
Zip code
Address
Sctor 48, Noida, India 201301
TEL
+911204215085
brahul_2371@yahoo.co.in
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Deshbandhu Sood |
Organization
Citizen Right Protection Forum
Division name
NGO
Zip code
Address
Sector 27 Noida
TEL
919817062276
Homepage URL
anujsafety@gmail.com
Sponsor or person
Institute
Laser Eye Clinic Noida
Institute
Department
Personal name
Funding Source
Organization
Laser Eye Clinic Noida
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
Rama Medical College Hospital, Pilkhuwa, Hapur, UP, India
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
http://www.bhargavaeyecare.in/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.bhargavaeyecare.in/
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 24 | Day |
Last modified on
| 2019 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040995
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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