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Comparing the effect of green tea extract and artificial tear in control of clinical symptoms, tear production, tear film stability, health of ocular surface and meibomian gland in the patients with dry eye and meibomian gland dysfunction.

Protocol summary

Summary
Objectives: To evaluate the efficacy and safety of green tea extract in the treatment of the patients with meibomian gland dysfunction and dry eye. Design: Clinical Trial stage 2, Single Center, Randomized, double blinded, control with placebo. Setting and conduct: We will select Sixty patients with dry eye that will divide 2 group. Age will range from 30 to 70 years. In the first group, we will use artificial tear eye drops and in second group artificial tears plus green tea extract. All Patients will evaluate at the beginning and end of the study (one month later) for signs of dry eye, tear production, tear film stability, ocular surface and Meibomian glands health. Major incliusion criteria included: Dry eye and meibomian gland dysfunction. Major exclusion criteria included: Use of ophthalmic medication in one month before study, ocular surface disorders such as corneal surface damage, eyelid complications and previous ocular surgery. Intervention: In the first group, we will use artificial tear eye drops and in second group artificial tears plus green tea extract. Main outcome measures (variables): Signs of dry eye, tear production, tear film stability, ocular surface and Meibomian glands health.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014042117374N1
Registration date: 2016-10-03, 1395/07/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-03, 1395/07/12
Registrant information
Name
Mehdi Zadmehr
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1629 1779
Email address
zadmehr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, shiraz university of medical sciences
Expected recruitment start date
2014-05-15, 1393/02/25
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of green tea extract and artificial tear in control of clinical symptoms, tear production, tear film stability, health of ocular surface and meibomian gland in the patients with dry eye and meibomian gland dysfunction.
Public title
Efficacy of green tea extract in the treatment of the patients with dry eye.
Purpose
Treatment
Inclusion/Exclusion criteria
Incliusion criteria included؛ Dry eye and meibomian gland dysfunction. Exclusion criteria included؛ Use of oral tetracyclines and corticosteroids in 3 months before study and all ophthalmic medication in one month before, Patients with other ocular surface disorders such as corneal surface damage, eyelid complications except blepharitis, any previous ocular surgery, history of drug allergy in eye , use of ophthalmic medication to treat other ophthalmic complication except dry eye and blepharitis, severe belepharitis and dry eye that require systemic treatment, Nasolacrimal duct system disorders such as punctal occlusion, Pregnancy and lactation, as well as patients taking systemic medications and systemic diseases affecting this study are excluded.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics committee
Street address
Central Building of the University, Across the flestin street, Zand street, Shiraz, Fars.
City
Shiraz
Postal code
7134997446
Approval date
2014-01-28, 1392/11/08
Ethics committee reference number
CT-P-92-5201

Health conditions studied

1

Description of health condition studied
Dry eye
ICD-10 code
VII
ICD-10 code description
Diseases of the eye and adnexa

Primary outcomes

1

Description
Clinical symptom
Timepoint
Before the intervention, one month after the intervention
Method of measurement
The questionnaire included: symptoms of itching, Burning, Reduced vision, Foreign body sensation, Pains, photophobia, Redness.

2

Description
Tear production
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Shirmer test

3

Description
Tear film stability
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Tear Film Brake Up Time test

4

Description
Ocular surface health
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Staining of the cornea and conjunctiva

5

Description
Meibomian glangd safety
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Color and quality of gland secretion

Secondary outcomes

1

Description
Drug allergy
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Clinical symptom

2

Description
Eye infection
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Clinical symptom

Intervention groups

1

Description
Intervention group: Artificial tear eye drop, one drop, three times a day for one month+ Green tea eye drop, one drop, three times a day for one month. For preparation of green tea drop, we brewed green tea then add a good amount of protective substances Benzalkonium Chloride under sterile conditions, filtrated and autoclaved. Amount of protective substances obvious with preservative challenge test.
Category
Treatment - Drugs

2

Description
Control group: Standard treatment include artificial tear eye drop one drop three times a day for one month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Poostchi Ophthalmology Clinic
Full name of responsible person
Mehdi Zadmehr Resident of ophthalmology
Street address
Opposite the school of Medicine, Shiraz, Zand street.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr basir hashemi
Street address
Central building of the University, Across the Flestin street, Zand street, Shiraz.
City
Shiraz
Grant name
طرح های پژوهشی دانشگاه
Grant code / Reference number
5201
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Zadmehr
Position
Resident of ophthalmology
Other areas of specialty/work
Street address
Central building of the university, Across the Flestin street, Zand street, Shiraz.
City
Shiraz
Postal code
7134814336
Phone
+98 711230541019
Fax
+98 71 1212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://www.sums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahmood Nejabat
Position
Anterior fellowship
Other areas of specialty/work
Street address
Central building of the university, Across the Flestin street, Zand street, Shiraz.
City
Shiraz
Postal code
7134814336
Phone
+98 711230541019
Fax
+98 71 1212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://www.sums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Zadmehr
Position
Resident of ophthalmology
Other areas of specialty/work
Street address
Central building of the university, Across the Flestin street, Zand street, Shiraz.
City
Shiraz
Postal code
7134814336
Phone
+98 711230541019
Fax
+98 71 1212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://www.sums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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