Effects of Cosopt on IOP and on Ocular Diastolic Perfusion Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Turin, Italy.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00796198
First received: November 21, 2008
Last updated: November 24, 2008
Last verified: November 2008
  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 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
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)
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
Active Comparator: Xalatan
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

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • POAG patients with a pattern deviation score (or its equivalent) ranging from 2.5 dB to 6.0 dB will be included in the study. This will ensure that patients with early/mid-stage glaucoma will be homogeneously collected; avoids advanced glaucoma in which OBF may behave as a different disease state.
  • 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:n

  • Normal tension glaucoma, ocular hypertension, cardiovascular and/or metabolic diseases (known to affect blood flow, as diabetes and polycythemia)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796198

Contacts
Contact: Teresa Rolle, MD 00390115666032 teresa.rolle@unito.it

Locations
Italy
University of Bari Not yet recruiting
Bari, Italy, 70124
Contact: Michele Vetrugno, MD    00 39 080 5592525    : m.vetrugno@oftalmo.uniba.it   
Sub-Investigator: Michele Vetrugno, MD         
University of Chieti Not yet recruiting
Chieti, Italy, 66100
Contact: Marco Ciancaglini, MD    0039 0871 358410    m.ciancaglini@unich.it   
Sub-Investigator: Marco Ciancaglini, MD         
University of Genova Not yet recruiting
Genova, Italy, 16132
Contact: Michele Iester, MD    00 39 010 3538469    iester@unige.it   
Sub-Investigator: Michele Iester, MD         
University of Siena Not yet recruiting
Siena, Italy, 53100
Contact: Paolo Frezzotti, MD    00 39 0577 233360    frezzottip@unisi.it   
Sub-Investigator: Paolo Frezzotti, MD         
University of Turin Not yet recruiting
Turin, Italy, 10143
Contact: Teresa Rolle, MD    00390115666032    teresa.rolle@unito.it   
Principal Investigator: Teresa Rolle, MD         
Sponsors and Collaborators
University of Turin, Italy
Investigators
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

No publications provided

Responsible Party: Rolle Teresa, MD,, University of Turin, Department of di Physiopathology Clinic-Section of Ophthalmology-Eye Clinic
ClinicalTrials.gov Identifier: NCT00796198     History of Changes
Other Study ID Numbers: COS16102007
Study First Received: November 21, 2008
Last Updated: November 24, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by University of Turin, Italy:
Glaucoma
Intraocular pressure
Ocular diastolic perfusion pressure
Dorzolamide/timolol Fixed combination
Heidelberg Retina Flowmeter

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014