GlaucomaPhase 4NCT01448837
24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice
A Phase 4 study testing Bimatoprost/Timolol, 24-hour intraocular pressure monitoring and Latanoprost, 24-hour intraocular pressure monitoring in people with Glaucoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Bimatoprost/Timolol, 24-hour intraocular pressure monitoring and Latanoprost, 24-hour intraocular pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to Mar 2011
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years
- Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye
- Study patients should have mild to moderate exfoliative glaucoma (VF loss <12 dB; cupping 0.8 or less)
- Patient with exfoliation syndrome should fulfill the IOP criterion (IOP > 29 mm Hg at 10:00)
- Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP
- Patient agrees to be treated for at least 3 months with latanoprost and bimatoprost/timolol fixed combination drops dosed in the evening
- In study eye distance best corrected Snelen visual acuity greater than 1/10
Who cannot join
- Contraindications to therapy with latanoprost, bimatoprost, or β-blockers
- History of non-adherence or previously recorded evidence of lack of response (<10% morning IOP reduction) to any antiglaucoma medication
- Patient can not understand the instructions and adhere to medications
- Patient is a female of childbearing potential or lactating mother
- Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- Signs of ocular infection, except blepharitis, or corneal abnormality that may affect IOP measurements
- The other eye can not receive the same therapy, or remain without medical therapy
- Closed angles
Trial locations and contacts
1 site in 1 country.
Greece1 site
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki
About this study
Official title: 24-Hour Intraocular Pressure Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma
The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.
- Conditions
- Glaucoma
- Being tested
- Bimatoprost/Timolol, 24-hour intraocular pressure monitoring, Latanoprost, 24-hour intraocular pressure monitoring
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost/Timolol, 24-hour intraocular pressure monitoringDrug
Also called Ganfort, Xalatan
Administered once in the evening
Latanoprost, 24-hour intraocular pressure monitoringDrug
Also called Ganfort, Xalatan
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost/Timolol drops | Active comparator | The patients will be treated with bimatoprost/timolol fixed combination therapy Receives: Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring; Drug: Latanoprost, 24-hour intraocular pressure monitoring |
| Latanoprost drops | Active comparator | The patients will be crossed over to therapy with latanoprost Receives: Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring; Drug: Latanoprost, 24-hour intraocular pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour IOP reduction between the two medications
Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg).
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 posted7 Oct 2011 (estimated)
- Study startApr 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 37 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 G Konstas, MD, PhD, Principal investigator, Glaucoma Unit, 1st University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448837
- Sponsor's protocol ID
- A5134
- Status last verified
- May 2014
- First submitted
- 26 Sep 2011
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- 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 Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma
- ClinicalTrials.gov ID
- NCT01448837
- Acronym / sponsor ID
- A5134
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Oct 2011 (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 primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost/Timolol drops | Active comparator | Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring, Drug: Latanoprost, 24-hour intraocular pressure monitoringThe patients will be treated with bimatoprost/timolol fixed combination therapy |
| Latanoprost drops | Active comparator | Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring, Drug: Latanoprost, 24-hour intraocular pressure monitoringThe patients will be crossed over to therapy with latanoprost |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years
- Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye
- Study patients should have mild to moderate exfoliative glaucoma (VF loss <12 dB; cupping 0.8 or less)
- Patient with exfoliation syndrome should fulfill the IOP criterion (IOP > 29 mm Hg at 10:00)
- Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP
Key exclusion criteria (8 listed)
- Contraindications to therapy with latanoprost, bimatoprost, or β-blockers
- History of non-adherence or previously recorded evidence of lack of response (<10% morning IOP reduction) to any antiglaucoma medication
- Patient can not understand the instructions and adhere to medications
- Patient is a female of childbearing potential or lactating mother
- Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
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 |
|---|---|---|
| Bimatoprost/Timolol, 24-hour intraocular pressure monitoringAlso: Ganfort, XalatanAdministered once in the evening | Drug | Bimatoprost/Timolol drops, Latanoprost drops |
| Latanoprost, 24-hour intraocular pressure monitoringAlso: Ganfort, Xalatanassessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing | Drug | Bimatoprost/Timolol drops, Latanoprost drops |
Primary outcome
24-hour IOP reduction between the two medications
Time frame: 3 months
Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg).
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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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 G Konstas, MD, PhD principal investigator
Glaucoma Unit, 1st University Department of Ophthalmology
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 Bimatoprost/Timolol, 24-hour intraocular pressure monitoring and Latanoprost, 24-hour intraocular pressure monitoring 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 7 inclusion and 8 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?
24-hour IOP reduction between the two medications (time frame: 3 months). It is what the study was designed to measure, not a finding.
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.