Open-Angle GlaucomaPhase 4NCT00273481
Cosopt Versus Xalacom
A Phase 4 study testing dorzolamide 2%/timolol maleate 0.5% fixed combination, latanoprost 0.005%/timolol maleate 0.5% fixed combination and timolol maleate 0.5% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Pharmaceutical Research Network at 2 sites in 2 countries.
Trial summary
To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- dorzolamide 2%/timolol maleate 0.5% fixed combination, latanoprost 0.005%/timolol maleate 0.5% fixed combination and timolol maleate 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2005to Apr 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension
- at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before
- the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2
- visual acuity should be 6/60 or better in the study eye(s)
Who cannot join
- any anticipated change in systemic hypotensive therapy during the trial
- use of any corticosteroids by any route for more than two weeks during the study
- contraindications to study medicines
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- dorzolamide 2%/timolol maleate 0.5% fixed combination, latanoprost 0.005%/timolol maleate 0.5% fixed combination, timolol maleate 0.5%, placebo
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dorzolamide 2%/timolol maleate 0.5% fixed combinationDrug
latanoprost 0.005%/timolol maleate 0.5% fixed combinationDrug
timolol maleate 0.5%Drug
placeboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startSep 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-Angle 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 33 participants
Sponsor and investigators
- Lead sponsor
- Pharmaceutical Research Network
- Sponsor type
- University, hospital or other
- Investigators
- William C. Stewart, MD, Study director, Pharmaceutical Research Network, LLCCindy M. Hutnik, BSc, PhD, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sBarbara Cvenkel, MD, Principal investigator, University Eye Clinic Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273481
- Sponsor's protocol ID
- PRN 05-001
- Status last verified
- Nov 2008
- First submitted
- 6 Jan 2006
- Last updated
- 19 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosopt Versus Xalacom
- ClinicalTrials.gov ID
- NCT00273481
- Acronym / sponsor ID
- PRN 05-001
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants
- Lead sponsor
- Pharmaceutical Research NetworkUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Jan 2006 (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.
To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension
- at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before
- the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2
- visual acuity should be 6/60 or better in the study eye(s)
Key exclusion criteria (3 listed)
- any anticipated change in systemic hypotensive therapy during the trial
- use of any corticosteroids by any route for more than two weeks during the study
- contraindications to study medicines
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 |
|---|---|---|
| dorzolamide 2%/timolol maleate 0.5% fixed combination | Drug | – |
| latanoprost 0.005%/timolol maleate 0.5% fixed combination | Drug | – |
| timolol maleate 0.5% | Drug | – |
| placebo | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
William C. Stewart, MD study director
Pharmaceutical Research Network, LLC
Cindy M. Hutnik, BSc, PhD, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Barbara Cvenkel, MD principal investigator
University Eye Clinic Ljubljana
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dorzolamide 2%/timolol maleate 0.5% fixed combination, latanoprost 0.005%/timolol maleate 0.5% fixed combination and timolol maleate 0.5% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Pharmaceutical Research Network at 2 sites in 2 countries.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 19 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 2 sites in Canada, Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 19 Nov 2008.