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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035991
Receipt No. 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

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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
Email 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
Email anujsafety@gmail.com

Sponsor
Institute Laser Eye Clinic Noida
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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