Purpose of this study is comparing efficacy and side effects of Latanoprost versus Timolol on decreasing IOP in patients with open angle glaucoma visiting Imam Hossein Hospital of Shahrood during March 2015-March 2016; and this goal will perform according to sex and age-groups.
This study is randomized, single blind, without placebo-controlled group and in one center will perform and patients will not be informed from type of intervention.
Samples after the first wash out period (if they used ophthalmic drop) will separate to two groups according to randomized complete block design. Then one group will receive Latanoprost drop and the other will receive Timolol drop.
After the second wash out period the other drug will prescribe. During wash out periods Dorzolamide drop will prescribe to control IOP.
Inclusion criteria include open angle glaucoma or ocular hypertension and exclusion criteria include IOP>30mmHg and existing any other ocular disorder except glaucoma.
Target sample size is 40.
Intervention includes measuring IOP by the ophthalmologist with applanation Haag-Streit tonometer.
Study will perform during March 2015-March 2016.
Outcome of this study will compare efficacy and side effects of two mentioned drugs in decreasing IOP.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042021875N1
Registration date:2016-09-18, 1395/06/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-18, 1395/06/28
Registrant information
Name
Negin Ebrahimi
Name of organization / entity
Medical University of Islamic Azad University of Shahroud
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 0360
Email address
med.rsh@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr Sahebali Manafi (vice chancellor for research and technology of Islamic Azad University of Shahrood)
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and side effects of Latanoprost versus Timolol on decreasing IOP in patients with glaucoma
Public title
Comparison of efficacy of two ophthalmic drops on decreasing intraocular pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of open angle glaucoma symptoms; ocular hypertension includes patients with increased IOP; glaucomatous cupping (cup to disc ratio between 0.4 - 0.7; disc-cup asymmetry>0.2; notching of the rim; enlargement of the cup; bleeding of the rim of the disc; degeneration of the nerve fiber layer)
Exclusion criteria:
Secondary causes of increasing IOP; cup to disc ratio>0.7; IOP>30 mmHg in each stage of the disease; existing of any other ocular disorder except glaucoma; corrected vision less than 20/50; bradycardia; asthma; COPD; consumption of any drug affecting IOP for example beta blockers, corticosteroids, carbonic anhydrase inhibitors, nitrates and alpha 2 agonists; discontent of patient.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee on medical ethics of Medical University of Shahrood
Street address
Medical University of Shahrood, Haftom-e-tir Sq
City
Shahrood
Postal code
Approval date
2015-04-08, 1394/01/19
Ethics committee reference number
930/36
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40, H40.0
ICD-10 code description
Glaucoma, Glaucoma suspect
Primary outcomes
1
Description
Tonometry
Timepoint
Before intervention, if the first wash out period is needed every 2 weeks during 4 weeks, at the end of the first week, the first and third month, every 2 weeks during 4 weeks in the second wash out period and at the end of the first week, the first and third month after the second wash out period
Method of measurement
Applanation Haag-Streit tonometer
Secondary outcomes
1
Description
Refraction
Timepoint
Before intervention, at the end of the third month, at the end of the sixth month
Method of measurement
Refractor
2
Description
Gonioscopy
Timepoint
Before intervention, at the end of the third month, at the end of the sixth month
Method of measurement
Slit lamp
3
Description
Appointment of cup to disc ratio
Timepoint
Before intervention, at the end of the third month, at the end of the sixth month
Method of measurement
Slit lamp
4
Description
Eye irritation
Timepoint
Before intervention, if the first wash out period is needed every 2 weeks during 4 weeks, at the end of the first week, the first and third month, every 2 weeks during 4 weeks in the second wash out period and at the end of the first week, the first and third month after the second wash out period
Method of measurement
Questionnaire and examination by slit lamp
5
Description
Blurred vision
Timepoint
Before intervention, if the first wash out period is needed every 2 weeks during 4 weeks, at the end of the first week, the first and third month, every 2 weeks during 4 weeks in the second wash out period and at the end of the first week, the first and third month after the second wash out period
Method of measurement
Questionnaire and examination by slit lamp
Intervention groups
1
Description
Intervention group: Latanoprost ophthalmic drop 0.005% dripping one drop in each eye every night for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Timolol ophthalmic drop 0.5% dripping one drop in each eye twice a day for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahrood
Full name of responsible person
Negin Ebrahimi
Street address
Imam Hossein Hospital of Shahrood, Tohidi St, Imam Ave
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology of Islamic Azad University of Shahrood
Full name of responsible person
Dr Sahebali Manafi
Street address
Islamic Azad University of Shahrood, Daneshgah Blvd
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology of Islamic Azad University of Shahrood
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
Imam Hossein Hospital of Shahrood
Full name of responsible person
Negin Ebrahimi
Position
Medical student
Other areas of specialty/work
Street address
Imam Hossein Hospital of Shahrood, Tohidi St, Imam Ave