Back to results24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients
Primary Purpose
Primary Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
timolol maleate 0.5%
latanoprost/timolol fixed combination
placebo (artificial tears)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma
Eligibility Criteria
Inclusion Criteria: POAG OHT Exclusion Criteria: Advanced glaucoma Arterial Hypertension
Sites / Locations
- Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00330577
First Posted
May 26, 2006
Last Updated
May 9, 2014
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT00330577
Brief Title
24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients
Official Title
24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the short-term mean 24-hour intraocular pressure control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination given once in the evening with placebo once in the morning versus timolol maleate 0.5% given twice daily in patients with ocular hypertension and primary open-angle glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
timolol maleate 0.5%
Intervention Type
Drug
Intervention Name(s)
latanoprost/timolol fixed combination
Intervention Type
Drug
Intervention Name(s)
placebo (artificial tears)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
POAG
OHT
Exclusion Criteria:
Advanced glaucoma
Arterial Hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AGP Konstas, MD, PhD
Organizational Affiliation
Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
12. IPD Sharing Statement
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24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients
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