Effects of Cosopt on IOP and on Ocular Diastolic Perfusion Pressure
Recruitment status was Not yet recruiting
Hypothesis: Studies suggest that patients with low diastolic velocity and high resistivity index in the ophthalmic artery had more progressive visual fields, the investigators hypothesize therefore that addition of Cosopt to Latanoprost could improve ocular diastolic perfusion pressure (ODPP).
Objective: To evaluate the effects of Cosopt on ODPP in patients not adequately controlled with latanoprost alone.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study on the Effects of Cosopt on IOP Lowering and Ocular Diastolic Perfusion Pressure in Patients Not Controlled With Xalatan Monotherapy|
- To evaluate the effects of Cosopt on ODPP in patients not adequately controlled with latanoprost alone [ Time Frame: baseline, at 1 and 3 months ] [ Designated as safety issue: No ]
- To evaluate the effects of Cosopt on IOP lowering in patients not adequately controlled with latanoprost alone. [ Time Frame: baseline, at 1 and 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||July 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Xalatan+Cosopt
Cosopt will be added to Xalatan when Xalatan is effective but not sufficient to reach the target pressure (Add group) (n = 25)
Xalatan ophthalmic solution one drop at 10pm + Cosopt ophthalmic solution one drop at 8am and one drop at 8 pmDrug: Xalatan
Xalatan ophthalmic solution one drop at 10pm
Active Comparator: Xalatan
when Xalatan is effective and sufficient to reach the target pressure no other medication will be added (control group) (n = 25)
Xalatan ophthalmic solution one drop at 10pm
Fifty patients with primary open angle glaucoma (POAG) treated with Xalatan for whom the monotherapy was not sufficient to achieve the target IOP, will be included in the study. Non responders were defined when IOP was > 20 mmHg or if the IOP reduction was less than 25% from the baseline IOP. Patients will be classified as having POAG when they had a typical glaucomatous visual field and/or a typical abnormal optic nerve head, open angle at gonioscopy, IOP > 21 mmHg with no treatment and no clinically apparent secondary cause for their glaucoma (EGS guidelines).
Visual fields will be assessed by an Humphrey Field Analyzer 750 (HFA, Humphrey, Inc, CA, USA), 24-2 SITA (Swedish Interactive Threshold Algorithm) standard. A glaucomatous visual field defect was defined as: 1) three adjacent points depressed by 5 dB, with one of the points depressed by at least 10 dB; 2) two adjacent points depressed by 10 dB; or 3) a 10 dB difference across the nasal horizontal meridian in two adjacent points. None of the points could be edge points unless immediately above or below the nasal horizontal meridian. In addition, visual field testing was considered reliable only when false-negative responses were less than 30% and fixation losses were less than 20% on HFA.
The abnormal optic nerve head classification was based on the presence of an optic rim notch or of diffuse / generalized loss of optic rim tissue, vertical cup/disc diameter ratio asymmetry unexplained by side differences in optic disc size, disc haemorrhage.
In each centre, patient's recruitment will start as soon as the ethical committee will approve the protocol. Each sites will recruit 10 patients (5 + 5).
Cosopt will be added to Xalatan when Xalatan is effective but not sufficient to reach the target pressure (Add group) (n = 25), while when Xalatan is effective and sufficient to reach the target pressure no other medication will be added (control group) (n = 25).
(EGS guidelines: Target pressure is a subjective value that none is able to assess (until now!). Efficacy of a drug: when the medication can decrease IOP as described in the phase three of their clinical trial. Not sufficient: when the medication is effective but is not able to reach the target IOP.)
Each patient will be submitted to three different visits:
- Baseline visit: Systemic Pressure, IOP, VF, HRF, Visual Acuity, ophthalmic examination with corneal central thickness (CCT)
- Visit at 1 month: Systemic Pressure , IOP, Visual Acuity, ophthalmic examination
- Visit at 3 months: Systemic Pressure, IOP , HRF, Visual Acuity, ophthalmic examination (+ CCT) ODPP will be calculated by: "systemic diastolic pressure - IOP" at each session.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796198
|Contact: Teresa Rolle, MDemail@example.com|
|University of Bari||Not yet recruiting|
|Bari, Italy, 70124|
|Contact: Michele Vetrugno, MD 00 39 080 5592525 : firstname.lastname@example.org|
|Sub-Investigator: Michele Vetrugno, MD|
|University of Chieti||Not yet recruiting|
|Chieti, Italy, 66100|
|Contact: Marco Ciancaglini, MD 0039 0871 358410 email@example.com|
|Sub-Investigator: Marco Ciancaglini, MD|
|University of Genova||Not yet recruiting|
|Genova, Italy, 16132|
|Contact: Michele Iester, MD 00 39 010 3538469 firstname.lastname@example.org|
|Sub-Investigator: Michele Iester, MD|
|University of Siena||Not yet recruiting|
|Siena, Italy, 53100|
|Contact: Paolo Frezzotti, MD 00 39 0577 233360 email@example.com|
|Sub-Investigator: Paolo Frezzotti, MD|
|University of Turin||Not yet recruiting|
|Turin, Italy, 10143|
|Contact: Teresa Rolle, MD 00390115666032 firstname.lastname@example.org|
|Principal Investigator: Teresa Rolle, MD|
|Principal Investigator:||Teresa Rolle, MD, Assistent Professor||University of Turin, Department of Clinical Physiopathology, Section of Ophthalmology, Eye Clinic|
|Principal Investigator:||Teresa Rolle, MD, Assistent Professor||University of Turin, Department of Clinical Physiopathology-Section of Ophthalmology-Eye Clinic|