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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033956
Receipt No. R000038732
Scientific Title 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 2019/09/06

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Basic information
Public title To compare safety and efficacy of topical Tacrolimus (0.03%) and dexamethasone (0.05%) for subepithelial infiltrates after adenoviral conjunctivitis.
Acronym Tacro vs Dexa for subepithelial infiltrates.
Scientific Title To compare safety and efficacy of topical Tacrolimus (0.03%) and dexamethasone (0.05%) for subepithelial infiltrates after adenoviral conjunctivitis.
Scientific Title:Acronym 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
1st name Rahul
Middle name
Last name Bhargava
Organization Laser Eye Clinic, Noida
Division name Ophthalmology
Zip code 201301
Address Sector 48 noida
TEL +91204215085
Email brahul_2371@yahoo.co.in

Public contact
Name of contact person
1st name Deshbandhu
Middle name
Last name Sood
Organization Citizen Right Protection Forum
Division name NGO
Zip code 201301
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)

IRB Contact (For public release)
Organization Rama Medical College
Address Hapur
Tel 01204259971
Email indianmedicalstats@gmail.com

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

Related information
URL releasing protocol http://www.ijo.in/temp/IndianJOphthalmol675594-5873368_013753.pdf
Publication of results Published

Result
URL related to results and publications jo.in/downloadpdf.asp?issn=0301-4738;year=2019;volume=67;issue=5;spage=594;epage=598;aulast=Bhargava
Number of participants that the trial has enrolled 90
Results
9
Results date posted
2019 Year 09 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 04 Month 22 Day
Baseline Characteristics
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Participant flow
Consecutive patients with SEI were randomly allocated to 1 of the 2 groups by a parallel assignment (1:1). The allocation codes were generated by a web-based module and was stratified according to clinical center with a permuted block method with randomly chosen block sizes. The generated codes were sealed in green envelopes and were opened by health care personnel not involved in patient care. The TACRO group received tacrolimus 0.03% ointment twice daily and DEXA group received dexamethasone 0.05% ointment twice daily for 6 months. The subjects were masked to the contents. The 2 types of ointments were like each other in appearance. The subjects were instructed to return the empty tubes on monthly visit, wherein 1 pack of ointment was provided to them. The regimen was reduced in frequency or suspended when the patient reported any symptoms or when a contraindication to treatment to any of active ointments developed. With resolution of symptoms or contraindications, the patient could restart or resume the regimen.
Adverse events
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Outcome measures
The primary outcome measure was mean change in baseline in the SEI score. Changes in visual acuity and intraocular pressure (safety outcomes), and the incidence of adverse events were secondary outcome measures. Coordinators asked patients about adverse events during each visit (at 1, 3, and 6 months). All patients, clinical staff, and laboratory personnel were unaware of the trial-group assignments.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 16 Day
Date of IRB
2017 Year 01 Month 01 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

Other
Other related information

Management information
Registered date
2018 Year 08 Month 30 Day
Last modified on
2019 Year 09 Month 06 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
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Research case data
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