GlaucomaPhase 4NCT00972257
24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination
A Phase 4 study testing treatment with dorzolamide/timolol and treatment with brimonidine/timolol in people with Glaucoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. Read more about this study
- Who is it for?
- Ages 29 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- treatment with dorzolamide/timolol and treatment with brimonidine/timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2009to Sep 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 29 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive, newly diagnosed or previously untreated POAG patients
- Patients with typical glaucomatous disc, or visual field damage
- Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg
Who cannot join
- Uncontrolled glaucoma
- Distance best corrected Snellen visual acuity worse than 1/10
- Contraindications to brimonidine or dorzolamide and β-blockers
- History of lack of response (<10% morning IOP reduction) to any medication
- Patient can not understand the instructions and adhere to medications
- Patient is a female of childbearing potential or lactating mother
Show all 10Show fewer
- Prior surgery, past use of steroids (within 2 months)
- Severe dry eyes and use of contact lenses
- History of non-adherence
- Patients with closed angles
Trial locations and contacts
1 site in 1 country.
Greece1 site
Glaucoma Unit, 1st University Dept of Ophthalmology
Thessaloniki, 546 36
About this study
Official title: Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma
The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.
- Conditions
- Glaucoma
- Being tested
- treatment with dorzolamide/timolol, treatment with brimonidine/timolol
- Keywords
- 24-hour IOP control, primary open-angle glaucoma, brimonidine/timolol, dorzolamide/timolol
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with dorzolamide/timololDrug
24-hour IOP control with the two fixed combinations
treatment with brimonidine/timololDrug
24-hour pressure control with brimonidine/timolol
| Study group | Role | What they receive |
|---|---|---|
| Drug: Dorzolamide/Timolol | Active comparator | Not described Receives: Drug: treatment with dorzolamide/timolol |
| Treatment with Brimonidine/Timolol | Active comparator | Not described Receives: Drug: treatment with brimonidine/timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.
Measured: 3 months
Secondary outcomes (1)
Assess fluctuation of 24-hour pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
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
- Anastasios Konstas, MD, phD, Principal investigator, Head of Glaucoma Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972257
- Sponsor's protocol ID
- A5132
- Status last verified
- May 2014
- First submitted
- 3 Sep 2009
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Konstas AG, Quaranta L, Yan DB, Mikropoulos DG, Riva I, Gill NK, Barton K, Haidich AB. Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma. Eye (Lond). 2012 Jan;26(1):80-7. doi: 10.1038/eye.2011.239. Epub 2011 Sep 30.
PubMed 21960068
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
- Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT00972257
- Acronym / sponsor ID
- A5132
- Conditions
- Glaucoma
- Keywords
- 24-hour IOP control, primary open-angle glaucoma, brimonidine/timolol, dorzolamide/timolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Sep 2009 (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 proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Dorzolamide/Timolol | Active comparator | Drug: treatment with dorzolamide/timolol |
| Treatment with Brimonidine/Timolol | Active comparator | Drug: treatment with brimonidine/timolol |
Who may qualify
- Ages
- 29 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive, newly diagnosed or previously untreated POAG patients
- Patients with typical glaucomatous disc, or visual field damage
- Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg
Key exclusion criteria (10 listed)
- Uncontrolled glaucoma
- Distance best corrected Snellen visual acuity worse than 1/10
- Contraindications to brimonidine or dorzolamide and β-blockers
- History of lack of response (<10% morning IOP reduction) to any medication
- Patient can not understand the instructions and adhere to medications
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 |
|---|---|---|
| treatment with dorzolamide/timolol24-hour IOP control with the two fixed combinations | Drug | Drug: Dorzolamide/Timolol |
| treatment with brimonidine/timolol24-hour pressure control with brimonidine/timolol | Drug | Treatment with Brimonidine/Timolol |
Primary outcome
To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.
Time frame: 3 months
1 secondary outcome
Assess fluctuation of 24-hour pressure
Time frame: 3 months
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.
- Derived from this study: PubMed 21960068Konstas AG, Quaranta L, Yan DB, Mikropoulos DG, Riva I, Gill NK, Barton K, Haidich AB. Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma. Eye (Lond). 2012 Jan;26(1):80-7. doi: 10.1038/eye.2011.239. Epub 2011 Sep 30.
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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.
Anastasios Konstas, MD, phD principal investigator
Head of Glaucoma Unit
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 treatment with dorzolamide/timolol and treatment with brimonidine/timolol in people with Glaucoma, 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 3 inclusion and 10 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.
What does the primary outcome measure?
To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972257, which also lists 1 linked publication.
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.