Ocular HypertensionPhase 4NCT00273442
Assessing Cosopt Switch Patients
A Phase 4 study testing timolol maleate and dorzolamide/timolol maleate fixed combination in people with Ocular Hypertension and Open-Angle Glaucoma, run by Pharmaceutical Research Network at 5 sites in United States.
Trial summary
To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open-Angle Glaucoma, Exfoliation Syndrome
- What is being tested?
- timolol maleate and dorzolamide/timolol maleate fixed combination
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 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 clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
- the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
- visual acuity should be 20/200 or better in each eye
Who cannot join
- contraindications to study drugs
- anticipated change in systemic hypotensive therapy during the trial
- use of any corticosteroids by any route in the three months immediately prior to Visit 2
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Omni Eye Services
Atlanta, Georgia, 30342
Midwest Eye Center
Bourbonnais, Illinois, 60914
Little Rock Eye Clinic
Little Rock, Arkansas, 72205
Glaucoma Consultants & Center for Eye Research
Mt. Pleasant, South Carolina, 29464
Mark J. Weiss, MD
Tulsa, Oklahoma, 74104
About this study
To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.
- Being tested
- timolol maleate, dorzolamide/timolol maleate fixed combination
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timolol maleateDrug
dorzolamide/timolol maleate fixed combinationDrug
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 startNov 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 Ocular HypertensionStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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, LLCMark J. Weiss, MD, Principal investigatorDouglas G. Day, MD, Principal investigator, Omni Eye ServicesSriram Sonty, MD, FACS, Principal investigator, Midwest Eye CenterJ. Charles Henry, MD, Principal investigator, Little Rock Eye ClinicElizabeth D. Sharpe, MD, Principal investigator, Glaucoma Consultants & Center for Eye Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273442
- Sponsor's protocol ID
- PRN 05-007
- 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
- Assessing Cosopt Switch Patients
- ClinicalTrials.gov ID
- NCT00273442
- Acronym / sponsor ID
- PRN 05-007
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Pharmaceutical Research NetworkUniversity, hospital or other
- Study start
- Nov 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 assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
- the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
- visual acuity should be 20/200 or better in each eye
Key exclusion criteria (3 listed)
- contraindications to study drugs
- anticipated change in systemic hypotensive therapy during the trial
- use of any corticosteroids by any route in the three months immediately prior to Visit 2
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 |
|---|---|---|
| timolol maleate | Drug | – |
| dorzolamide/timolol maleate fixed combination | 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
Mark J. Weiss, MD principal investigator
Douglas G. Day, MD principal investigator
Omni Eye Services
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 timolol maleate and dorzolamide/timolol maleate fixed combination in people with Ocular Hypertension and Open-Angle Glaucoma, run by Pharmaceutical Research Network at 5 sites in United States.
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 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 5 sites in United States. 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.