Primary Open Angle GlaucomaPhase 4NCT00330577
24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients
A Phase 4 study testing timolol maleate 0.5% and latanoprost/timolol fixed combination in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose of this study is to compare the short-term mean 24-hour intraocular pressure control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination given once in the evening with placebo once in the morning versus timolol maleate 0.5% given twice daily in patients with ocular… Read more about this study
- Who is it for?
- Ages 29 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- timolol maleate 0.5% and latanoprost/timolol fixed combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2006to Jul 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 29 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- POAG
- OHT
Who cannot join
- Advanced glaucoma
- Arterial Hypertension
Trial locations and contacts
1 site in 1 country.
Greece1 site
Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
Thessaloniki, 546 36
About this study
The purpose of this study is to compare the short-term mean 24-hour intraocular pressure control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination given once in the evening with placebo once in the morning versus timolol maleate 0.5% given twice daily in patients with ocular hypertension and primary open-angle glaucoma.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- timolol maleate 0.5%, latanoprost/timolol fixed combination, placebo (artificial tears)
- 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
latanoprost/timolol fixed combinationDrug
placebo (artificial tears)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- 30 participants
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AGP Konstas, Aristotle University Of Thessaloniki
- Investigators
- AGP Konstas, MD, PhD, Principal investigator, Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330577
- Sponsor's protocol ID
- A594
- Status last verified
- May 2014
- First submitted
- 26 May 2006
- Last updated
- 12 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients
- ClinicalTrials.gov ID
- NCT00330577
- Acronym / sponsor ID
- A594
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 May 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.
The purpose of this study is to compare the short-term mean 24-hour intraocular pressure control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination given once in the evening with placebo once in the morning versus timolol maleate 0.5% given twice daily in patients with ocular hypertension and primary open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 29 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- POAG
- OHT
Key exclusion criteria (2 listed)
- Advanced glaucoma
- Arterial Hypertension
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 | – |
| latanoprost/timolol fixed combination | Drug | – |
| placebo (artificial tears) | 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 12 May 2014.
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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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.
AGP Konstas, MD, PhD principal investigator
Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
1 site 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% and latanoprost/timolol fixed combination in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 2 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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 12 May 2014.