Protocol summary
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Study aim
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Comparative evaluation of the efficacy of Nano formulation of Tacrolimus and Cyclosporine eye drops in patients with dry eye
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Design
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A randomized clinical trial was conducted using table of random numbers, double-blind, and parallel group design with 24 patients with dry eye syndrome, followed up for one month.
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Settings and conduct
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On 24 patients with dry eye syndrome referred from the rheumatology clinic, Ocular Surface Disease Index (OSDI)
questionnaire, Schirmer test, Tear film break up time test (TBUT)and Sm-tube and the slit lamp examination in Ophthalmology Clinic Vali Asr done. After confirming dry eye, the patient is given Nano-tacrolimus and cyclosporine drugs for use in each eye for one month and every two weeks they were followed-up for possible adverse side-effects . The ophthalmologist does not know which drug is used.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with burning symptoms, foreign body sensation and dryness in both eyes,blurring of vision, photo phobia,and pain, abnormal Schirmer test, TBUT test,OSDI index and SM tube enrolled in the study.
Exclusion criteria: pregnancy and lactation, patients with any structural disorder, any inflammation in the anterior chamber, glaucoma, previous eye surgery, recent use of topical or systemic antibiotics or anti-inflammatory drugs, contact lenses, corneal infections.
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Intervention groups
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Tacrolimus drops for one eye and Cyclosporine for other eyes twice a day for one month.
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Main outcome variables
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Measuring of schirmer test, SM-Tube,TBUT and OSDI
General information
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Reason for update
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1. Changing the scientific and public title due to more appropriateness and better observance of English writing
2. Changing the study phase to phase 3 because the previous phases have been done
3. Age change due to the ineffectiveness of age in the study
4. Changing the inclusion criteria because Sjogren is one of the causes of dry eye and patients other than Sjogren with dry eye were included in the study.
5. Changing the exclusion criteria due to duplication and incompleteness
6. Randomization change due to sample size change
7. Changing the sample size due to the lack of financial budget and sanctions on raw materials for drug production
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181006041253N1
Registration date:
2019-01-08, 1397/10/18
Registration timing:
registered_while_recruiting
Last update:
2021-06-14, 1400/03/24
Update count:
1
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Registration date
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2019-01-08, 1397/10/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2019-01-21, 1397/11/01
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Actual recruitment start date
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2018-12-22, 1397/10/01
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Actual recruitment end date
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2019-01-21, 1397/11/01
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Trial completion date
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2019-01-21, 1397/11/01
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Scientific title
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Comparative clinical evaluation of 0.05% Cyclosporine and 0.05% Nano -Tacrolimus eye drops for the treatment of dry eye
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Public title
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Nano-Tacrolimus and Cyclosporine effect in dry eye
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
chronic symptoms of burning, foreign body sensation or itching in both eyes, blurring of vision, photo phobia,and pain
daily need for artificial tears
The ocular surface disease index (OSDI)≥23
tear film break-up time (TBUT) value of 10s or lower
Strip Meniscometry test (SM tube) ≤ 10 mm
Schirmer test value at 5 min of 10mm or lower
Exclusion criteria:
Sensitivity to tacrolimus
Pregnancy or lactation
Other systemic atopic diseases
Previous eye surgery
Any structural abnormalities (lid scarring, entropion, trichiasis, etc.)
Any inflammation in the anterior chamber
Glaucoma
Use of other topical drugs, other than artificial tears
Use of topical or systemic antibiotics or anti-inflammatory drugs before entering the study
Contact lens
punctual occlusion
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Age
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From 30 years old to 78 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
24
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We assigned patients a code from 1 to 12. Then we used a table of random numbers to select 12 numbers. For the 12 selected patients, the 0.05% Nano- Tacrolimus drug was used in the right eye and the 0.05% CsA drug was used in the left eye. On the other 12 patients, 0.05% Nano- Tacrolimus was used in the left eye and the 0.05% CsA drug was used in the right eye
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study,the ophthalmologist who performs the examination and evaluation of the patients and the person who performs the data analysis is unaware of which drug is used.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-20, 1397/03/30
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Ethics committee reference number
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IR.BUMS.REC.1397.071
Health conditions studied
1
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Description of health condition studied
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Dry eye syndrome
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ICD-10 code
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H04.1
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ICD-10 code description
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Other disorders of lacrimal gland
Primary outcomes
1
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Description
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Foreign body sensation
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Timepoint
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Before intervention and one month after treatment
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Method of measurement
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Ocular Surface Disease Index (OSDI)
2
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Description
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Tear film break up time test (TBUT)
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Timepoint
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Before intervention and one month after treatment
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Method of measurement
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In seconds, with a timer and slit lamp
3
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Description
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Production of tears
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Timepoint
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Before intervention and one month after treatment
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Method of measurement
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Schirmer's test in millimeters
4
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Description
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Tear volume measurement (SM Tube)
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Timepoint
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Before intervention and one month after treatment
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Method of measurement
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The SM Tube strip is held in the lower lip for 5 seconds. After 5 seconds, the height of the absorbed tear of the blue column is measured.
5
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Description
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Light sensitivity
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Timepoint
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Before intervention and one month after treatment
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Method of measurement
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Ocular Surface Disease Index (OSDI)
6
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Description
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Blurred vision
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Timepoint
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Before intervention and one month after treatment
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Method of measurement
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Ocular Surface Disease Index (OSDI)
7
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Description
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Eye irritation
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Timepoint
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Before intervention and one month after treatment
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Method of measurement
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Ocular Surface Disease Index (OSDI)
Intervention groups
1
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Description
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International group 1: 0.05% nano formulation Tacrolimus drop produced at the Abu Reyhan Pharmacy Company for one eye twice a day, One drop use in the lower conjunctiva for one month.
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Category
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Treatment - Drugs
2
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Description
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International group 2: Cyclosporine drop Sinadarou Company uses a drop in the lower conjunctiva for one month twice a day for another eye.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Birjand University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Because of the publication of the article
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available