Effects of Cosopt on IOP and on Ocular Diastolic Perfusion Pressure
NCT ID: NCT00796198
Last Updated: 2008-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2008-12-31
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Objective: To evaluate the effects of Cosopt on ODPP in patients not adequately controlled with latanoprost alone.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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+Cosopt
Xalatan ophthalmic solution one drop at 10pm + Cosopt ophthalmic solution one drop at 8am and one drop at 8 pm
Xalatan
Xalatan ophthalmic solution one drop at 10pm
Xalatan
when Xalatan is effective and sufficient to reach the target pressure no other medication will be added (control group) (n = 25)
Xalatan
Xalatan ophthalmic solution one drop at 10pm
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Xalatan+Cosopt
Xalatan ophthalmic solution one drop at 10pm + Cosopt ophthalmic solution one drop at 8am and one drop at 8 pm
Xalatan
Xalatan ophthalmic solution one drop at 10pm
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Best-corrected visual acuity will be of 0.5 or better with an ametropia \<5D - Dioptric transparency, non smokers.
* Age will be between 45 and 65 years.
Exclusion Criteria
* Visual field defects other than glaucoma; use of vasoactive and/or anti-hypertensive drugs (systemic beta-blocker), use of acetazolamide
* Hypersensibility and/or contraindications to any of the molecules studied
* Previous ocular surgery
* Pregnant or nursing women and use of one of drugs for erectile dysfunction
45 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Turin, Italy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Turin, Department of di Physiopathology Clinic-Section of Ophthalmology-Eye Clinic
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teresa Rolle, MD, Assistent Professor
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Department of Clinical Physiopathology, Section of Ophthalmology, Eye Clinic
Teresa Rolle, MD, Assistent Professor
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Department of Clinical Physiopathology-Section of Ophthalmology-Eye Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Bari
Bari, , Italy
University of Chieti
Chieti, , Italy
University of Genova
Genova, , Italy
University of Siena
Siena, , Italy
University of Turin
Turin, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Michele Vetrugno, MD
Role: primary
Marco Ciancaglini, MD
Role: primary
Michele Iester, MD
Role: primary
Paolo Frezzotti, MD
Role: primary
Teresa Rolle, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COS16102007
Identifier Type: -
Identifier Source: org_study_id