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| Sponsor: | University of Turin, Italy |
|---|---|
| Information provided by: | University of Turin, Italy |
| ClinicalTrials.gov Identifier: | NCT00796198 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: Xalatan+Cosopt Drug: Xalatan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 50 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Xalatan+Cosopt: Active Comparator
Cosopt will be added to Xalatan when Xalatan is effective but not sufficient to reach the target pressure (Add group) (n = 25)
|
Drug: Xalatan+Cosopt
Xalatan ophthalmic solution one drop at 10pm + Cosopt ophthalmic solution one drop at 8am and one drop at 8 pm
Drug: Xalatan
Xalatan ophthalmic solution one drop at 10pm
|
|
Xalatan: Active Comparator
when Xalatan is effective and sufficient to reach the target pressure no other medication will be added (control group) (n = 25)
|
Drug: Xalatan
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:
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:n
Contacts and Locations| Contact: Teresa Rolle, MD | 00390115666032 | teresa.rolle@unito.it |
| Italy | |
| University of Turin | |
| Turin, Italy, 10143 | |
| University of Chieti | |
| Chieti, Italy, 66100 | |
| University of Siena | |
| Siena, Italy, 53100 | |
| University of Genova | |
| Genova, Italy, 16132 | |
| University of Bari | |
| Bari, Italy, 70124 | |
| 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 |
More Information
| Responsible Party: | University of Turin, Department of di Physiopathology Clinic-Section of Ophthalmology-Eye Clinic ( Rolle Teresa, MD, ) |
| Study ID Numbers: | COS16102007 |
| Study First Received: | November 21, 2008 |
| Last Updated: | November 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00796198 History of Changes |
| Health Authority: | Italy: Ethics Committee |
|
Glaucoma Intraocular pressure Ocular diastolic perfusion pressure Dorzolamide/timolol Fixed combination Heidelberg Retina Flowmeter |
|
Glaucoma Therapeutic Uses Eye Diseases Cardiovascular Agents |
Antihypertensive Agents Latanoprost Pharmacologic Actions Ocular Hypertension |