GlaucomaPhase 4NCT00796198
Effects of Cosopt on IOP and on Ocular Diastolic Perfusion Pressure
A Phase 4 study testing Xalatan+Cosopt and Xalatan in people with Glaucoma, run by University of Turin, Italy at 5 sites in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Xalatan+Cosopt and Xalatan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesItaly
- Study dates
- Dec 2008to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
University of Bari
Bari, 70124
Michele Vetrugno, MD, 00 39 080 5592525, : m.vetrugno@oftalmo.uniba.it
Michele Vetrugno, MD
University of Chieti
Chieti, 66100
Marco Ciancaglini, MD, 0039 0871 358410, m.ciancaglini@unich.it
Marco Ciancaglini, MD
University of Genova
Genova, 16132
Michele Iester, MD, 00 39 010 3538469, iester@unige.it
Michele Iester, MD
University of Siena
Siena, 53100
Paolo Frezzotti, MD, 00 39 0577 233360, frezzottip@unisi.it
Paolo Frezzotti, MD
University of Turin
Turin, 10143
Teresa Rolle, MD, 00390115666032, teresa.rolle@unito.it
Teresa Rolle, MD
About this 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
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Xalatan+Cosopt, Xalatan
- Keywords
- Glaucoma, Intraocular pressure, Ocular diastolic perfusion pressure, Dorzolamide/timolol Fixed combination, Heidelberg Retina Flowmeter
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xalatan+CosoptDrug
Xalatan ophthalmic solution one drop at 10pm + Cosopt ophthalmic solution one drop at 8am and one drop at 8 pm
XalatanDrug
Xalatan ophthalmic solution one drop at 10pm
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Xalatan+Cosopt; Drug: Xalatan |
| Xalatan | Active comparator | when Xalatan is effective and sufficient to reach the target pressure no other medication will be added (control group) (n = 25) Receives: Drug: Xalatan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of Cosopt on ODPP in patients not adequately controlled with latanoprost alone
Measured: baseline, at 1 and 3 months
Secondary outcomes (1)
To evaluate the effects of Cosopt on IOP lowering in patients not adequately controlled with latanoprost alone.
Measured: baseline, at 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Teresa Rolle, MD, Assistent Professor, Principal investigator, University of Turin, Department of Clinical Physiopathology, Section of Ophthalmology, Eye ClinicTeresa Rolle, MD, Assistent Professor, Principal investigator, University of Turin, Department of Clinical Physiopathology-Section of Ophthalmology-Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796198
- Sponsor's protocol ID
- COS16102007
- Status last verified
- Nov 2008
- First submitted
- 21 Nov 2008
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00796198
- Acronym / sponsor ID
- COS16102007
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Intraocular pressure, Ocular diastolic perfusion pressure, Dorzolamide/timolol Fixed combination, Heidelberg Retina Flowmeter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xalatan+Cosopt | Active comparator | Drug: Xalatan+Cosopt, Drug: XalatanCosopt will be added to Xalatan when Xalatan is effective but not sufficient to reach the target pressure (Add group) (n = 25) |
| Xalatan | Active comparator | Drug: Xalatanwhen Xalatan is effective and sufficient to reach the target pressure no other medication will be added (control group) (n = 25) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xalatan+CosoptXalatan ophthalmic solution one drop at 10pm + Cosopt ophthalmic solution one drop at 8am and one drop at 8 pm | Drug | Xalatan+Cosopt |
| XalatanXalatan ophthalmic solution one drop at 10pm | Drug | Xalatan, Xalatan+Cosopt |
Primary outcome
To evaluate the effects of Cosopt on ODPP in patients not adequately controlled with latanoprost alone
Time frame: baseline, at 1 and 3 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Rolle, MD, Assistent Professor principal investigator
University of Turin, Department of Clinical Physiopathology, Section of Ophthalmology, Eye Clinic
Teresa Rolle, MD, Assistent Professor principal investigator
University of Turin, Department of Clinical Physiopathology-Section of Ophthalmology-Eye Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xalatan+Cosopt and Xalatan in people with Glaucoma, run by University of Turin, Italy at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Rolle, MD (00390115666032, teresa.rolle@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of Cosopt on ODPP in patients not adequately controlled with latanoprost alone (time frame: baseline, at 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2008.