UMIN-CTR Clinical Trial

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 (Ver. 4)

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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

Corneal subepithelial infiltrates

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

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

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

years-old

Age-upper limit

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

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

Month

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

Results

Results date posted

2019

Year

Month

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2019

Year

Month

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

Month

Day

Date of IRB

2017

Year

Month

Day

Anticipated trial start date

2017

Year

Month

Day

Last follow-up date

2018

Year

Month

Day

Date of closure to data entry

2018

Year

Month

Day

Date trial data considered complete

2018

Year

Month

Day

Date analysis concluded

2018

Year

Month

Day

Other
Other related information

Management information

Registered date

2018

Year

Month

Day

Last modified on

2019

Year

Month

Day

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