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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033956
Receipt No. R000038732
Official scientific title of the study To compare safety and efficacy of topical Tacrolimus (0.03%) and dexamethasone (0.05%) for subepithelial infiltrates after adenoviral conjunctivitis.
Date of disclosure of the study information 2018/08/31
Last modified on 2018/08/30

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Basic information
Official scientific title of the study To compare safety and efficacy of topical Tacrolimus (0.03%) and dexamethasone (0.05%) for subepithelial infiltrates after adenoviral conjunctivitis.
Title of the study (Brief title) Tacro vs Dexa for subepithelial infiltrates.
Region
Asia(except Japan)

Condition
Condition Corneal subepithelial infiltrates
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare safety and efficacy of topical Tacrolimus (0.03%) and dexamethasone (0.05%) for subepithelial infiltrates (SEI) after adenoviral conjunctivitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase IV

Assessment
Primary outcomes The primary outcome measure was mean change in baseline in the subepithelialinfiltrate (SEI) score measured at four time pointa (baseline, 1 month, 3 months & six months)
Key secondary outcomes Changes in visual acuity and intraocular pressure (safety outcomes), and the incidence of adverse events were secondary outcome measures.

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
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The TACRO group received tacrolimus 0.03% ointment twice daily for 6 months
Interventions/Control_2 DEXA group received dexamethasone 0.05% ointment twice daily for 6 months.
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 Eligibility criteria were an age of 18 years or older, the presence of ocular symptoms like diminution of vision (corrected distance visual acuity of 6/9 Snellen or worse) for at least 4 weeks with SEIs following AK
Key exclusion criteria Patients who received any topical or systemic medications, had ocular disease like uveitis, glaucoma, or active keratitis, used corticosteroid eye drops; and those who had any ocular operations were excluded from the study.
Target sample size 38

Research contact person
Name of lead principal investigator Rahul Bhargava
Organization Laser Eye Clinic, Noida
Division name Ophthalmology
Address Sector 48 noida
TEL +91204215085
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 brahul_2371@yahoo.co.in

Sponsor
Institute Laser Eye Clinic Noida
Institute
Department

Funding Source
Organization None
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,

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 31 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 16 Day
Anticipated trial start date
2017 Year 01 Month 30 Day
Last follow-up date
2018 Year 06 Month 01 Day
Date of closure to data entry
2018 Year 06 Month 15 Day
Date trial data considered complete
2018 Year 07 Month 30 Day
Date analysis concluded
2018 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 30 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038732

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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