Glaucoma is an optic neuropathy that is associated with increased fluid pressure in the eyeball and progressively causes vision loss. Glaucoma is the second common cause of blindness after cataract and yet is one of the most important preventable causes of blindness. The aim of this study is to compare effectiveness of two combination therapy-Timolol/Latanoprost versus Timolol/Dorzolamide in reducing intraocular pressure in patients with primary open angle glaucoma. Plan: The study has been designed case-control and single blind. Methods and interventions: 60 eyes with primary open angle glaucoma will randomly divide into two groups. Variables such as intraocular pressure, visual acuity, and cup to disc ratio will be recorded. Both groups will receive 0.05% Timolol twice daily for six weeks and one group will receive 2% Dorzolamide twice daily and another group will receive 0.005% Latanoprost once daily and the variables will be evaluated again at the end of sixth week. Patients with secondary open-angle glaucoma, close-angle glaucoma, sensitivity to each of the drugs studied, patients with ocular herpes, patients who are pregnant or are breast-feeding and those with dry eyes who need to use eye drops five or more times per day will be excluded. The main outcome evaluated in this study is reduction in intraocular pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109047466N1
Registration date:2011-09-14, 1390/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-14, 1390/06/23
Registrant information
Name
Reza Rezaei
Name of organization / entity
Ophtalmologist
Country
Iran (Islamic Republic of)
Phone
+98 912 239 1814
Email address
dr.rezarezaei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Science, Research Council
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-08-22, 1390/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the fixed combinations latanoprost/ timolol versus dorzolamide / timolol in patients with primary open angle glaucoma
Public title
Efficacy and safety of the fixed combinations latanoprost/ timolol versus dorzolamide / timolol in patients with elevated intraocular pressure.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Primary open angle gluacoma
Exclusion criteria:
1- Secondary open angle glaucoma
2- Narrow-angle glaucoma
3- Allergy to trial drug
4- Ophthalmic herpes zoster
5- Pregnancy and lactation
6- Dry eyes that require use of ophtalmic drops is 5 times or more per day
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Science
Street address
Arak University of Medical Science.Alamolhoda Ave,Arak
City
Arak
Postal code
Approval date
2011-03-14, 1389/12/23
Ethics committee reference number
89-102-1
Health conditions studied
1
Description of health condition studied
Primary open-angle glaucoma
ICD-10 code
H40.1
ICD-10 code description
Glaucoma primary residual stage: capsular with pseudoexfoliation of lens . chronic simple . low-tension . pigmentary
Primary outcomes
1
Description
Decrease of intraocular pressure
Timepoint
In beginning of the study and the end of six weeks after treatment
Method of measurement
Goldmann Tonometry
Secondary outcomes
1
Description
Failure of treatment
Timepoint
End of treatment
Method of measurement
Goldmann Tonometry
2
Description
Drug side effects
Timepoint
During study
Method of measurement
Clinical evaluation
Intervention groups
1
Description
First group receive Timolol which is a non-specific blocker of beta-adrenergic receptor with concentration of 0.05%, twice daily for six weeks and also Latanoprost which is prostaglandin with concentration of 0.005%, once daily for six weeks.
Category
Treatment - Drugs
2
Description
Second group receive Timolol which is a non-specific blocker of beta-adrenergic receptor with concentration of 0.05%, twice daily for six weeks and also Dorzolamide which is Henle's loop diuretic with concentration of 2%, twice daily for six weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr reza rezaei
Street address
Amirkabir Hospital,Parastar Square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Dr. Davood hekmatpoour
Street address
Arak University of Medical Science,Basij Square,Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Science
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
Arak University of Medical Science
Full name of responsible person
Dr Reza Rezaei
Position
Assistant Professor
Other areas of specialty/work
Street address
Amirkabir Hospital,Parastar Square, Arak
City
Arak
Postal code
381961187
Phone
+98 86 1313 4715
Fax
+98 86 1313 2510
Email
dr.rezarezaei@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Science,Ophtalmology department
Full name of responsible person
Dr Reza Rezaei
Position
Ophtalmologist,Assistant Professor
Other areas of specialty/work
Street address
Amirkabir Hospital, Parastar Square, Arak
City
Arak
Postal code
381961187
Phone
+98 86 1313 4715
Fax
+98 86 1313 2510
Email
dr.rezarezaei@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Dr Reza Rezaei
Position
Ophtalmologist,Assistant Professor
Other areas of specialty/work
Street address
Amirkabir Hospital,Parastar Square,Arak
City
Arak
Postal code
381961187
Phone
+98 86 1313 4715
Fax
+98 86 1313 2510
Email
dr.rezarezaei@arakmu.ac.ir
Web page address
poral.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)