Among the primary and secondary open angle glaucoma cases who were treated with eye drop Lataprost 0.005% every night, with or without another medication and had proper IOP control, 50 eyes are selected randomly. In first phase, IOP checking is done basically, 4 and 6 weeks later. Then, in second phase, Lataprost dosage is changed to once every other day at bed time. Finally IOP checking is accomplished 1,2,4,6,8 and 12 weeks later and data will be evaluated by SPSS-17 software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108254166N4
Registration date:2011-12-03, 1390/09/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-03, 1390/09/12
Registrant information
Name
Rana Daei Sorkhabi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1655 1332
Email address
rana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-04-30, 1390/02/10
Expected recruitment end date
2012-02-29, 1390/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intraocular pressure lowering effect of Lataprost eye drop with once every other day dosing
Public title
Intraocular pressure lowering effect of Lataprost eye drop with once every other day dosing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1. Administering eye drop Lataprost % one time at night 2. At least two prior IOP checking in recent month 3. Appropriate IOP control with present medications 4. No prior intraocular surgery
Exclusion criteria: 1. Glaucoma surgery 2. Incomplete response to 2 antiglaucoma 3. Not possible to follow-up 4. Corneal problem that interferes with IOP checking 5. Ocular problem except cataract & glaucoma
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Latanoprost is an IOP lowering agent belonges to prostaglandine analoges. The Iranian brand of this medication is Lataprost 0.005% which is administered once at night.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St., Tabriz University of medical sciences
City
Tabriz
Postal code
Approval date
2011-04-11, 1390/01/22
Ethics committee reference number
5/4/1656
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40
ICD-10 code description
Glaucoma
Primary outcomes
1
Description
Intraocular Pressure
Timepoint
0, 1, 2, 4, 6, 8 and 12 weeks after
Method of measurement
Goldmann applanation
Secondary outcomes
empty
Intervention groups
1
Description
The design of this study is cross over ;in the 1st phase patients as case group receive the lataprost 0.005%with once daily dosage ;in the 2nd phase the same patients receive the drug with once every other day dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikukari Eye Hospital
Full name of responsible person
Dr Sorkhabi
Street address
Abbasi St., Nikukai Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of MedicalSciences
Full name of responsible person
Vice chancellor for research
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of MedicalSciences
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
Tabriz University of medical Sciences
Full name of responsible person
Dr Amizadeh
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Abbasi St., Nikukari Eye Hospital
City
Tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
yashar.amizadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Dr Rana Sorkhabi
Position
Ophthalmologist
Other areas of specialty/work
Street address
Abbasi St., Nikukari hospital
City
Tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
rana@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Yashar Amizadeh
Position
resident of Ophthalmology
Other areas of specialty/work
Street address
Abbasi St.
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)