Open-Angle GlaucomaPhase 4NCT00273429
Cosopt Versus Xalatan
A Phase 4 study testing timolol maleate 0.5%, dorzolamide/timolol maleate fixed combination and latanoprost 0.005% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Pharmaceutical Research Network at 2 sites in United States.
Trial summary
To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once 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?
- timolol maleate 0.5%, dorzolamide/timolol maleate fixed combination and latanoprost 0.005%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Apr 2005to Dec 2005
- 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, pigmentary, or exfoliation glaucoma, or ocular hypertenstion
- intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H
- ETDRS visual acuity must be 1.0 or better in both eyes
Who cannot join
- any contraindications to study medications
- any anticipated change in systemic hypertensive therapy during the trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Midwest Eye Center SC
Bourbonnais, Illinois, 60914
Central Florida Eye Associates
Lakeland, Florida, 33805
About this study
To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- timolol maleate 0.5%, dorzolamide/timolol maleate fixed combination, latanoprost 0.005%, 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.
timolol maleate 0.5%Drug
dorzolamide/timolol maleate fixed combinationDrug
latanoprost 0.005%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 startApr 2005
- Study completionDec 2005
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
Sponsor and investigators
- Lead sponsor
- Pharmaceutical Research Network
- Sponsor type
- University, hospital or other
- Investigators
- William C. Stewart, MD, Study director, Pharmaceutical Research Network, LLCJay Mulaney, MD, Principal investigator, Central Florida Eye AssociatesSriram Sonty, MD, FACS, Principal investigator, Midwest Eye Center SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273429
- Sponsor's protocol ID
- PRN 04-015
- Status last verified
- Jan 2007
- First submitted
- 6 Jan 2006
- Last updated
- 9 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosopt Versus Xalatan
- ClinicalTrials.gov ID
- NCT00273429
- Acronym / sponsor ID
- PRN 04-015
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Pharmaceutical Research NetworkUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Dec 2005
- 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 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once 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 (3 listed)
- adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion
- intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H
- ETDRS visual acuity must be 1.0 or better in both eyes
Key exclusion criteria (2 listed)
- any contraindications to study medications
- any anticipated change in systemic hypertensive therapy during the trial
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 0.5% | Drug | – |
| dorzolamide/timolol maleate fixed combination | Drug | – |
| latanoprost 0.005% | 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 9 Jan 2007.
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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
Jay Mulaney, MD principal investigator
Central Florida Eye Associates
Sriram Sonty, MD, FACS principal investigator
Midwest Eye Center SC
2 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 0.5%, dorzolamide/timolol maleate fixed combination and latanoprost 0.005% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Pharmaceutical Research Network at 2 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 2 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 9 Jan 2007. 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 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 9 Jan 2007.