UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033956 |
|---|---|
| Receipt number | 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 15:24:11 |
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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
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
brahul_2371@yahoo.co.in
Sponsor or person
Institute
Laser Eye Clinic Noida
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038732
