UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To compare safety and efficacy of cyclosporine 0.05% and cyclosporine 0.09% eyedrops for dry eye (keratoconjunctivitis).
Title of the study (Brief title)	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	Rahul Bhargava
Organization	Laser Eye Clinic, Noida
Division name	Ophthalmology
Address	Sctor 48, Noida, India 201301
TEL	+911204215085
Email	brahul_2371@yahoo.co.in

Public contact
Name of contact person	Deshbandhu Sood
Organization	Citizen Right Protection Forum
Division name	NGO
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 24 Day
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

Related information
URL releasing protocol	http://www.bhargavaeyecare.in/
Publication of results	Unpublished
URL releasing results	http://www.bhargavaeyecare.in/
Results
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