GlaucomaPhase 3NCT02154217
Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
A Phase 3 study testing Bimatoprost and Latanoprost/Timolol in people with Glaucoma, run by University of Milan at 9 sites in 5 countries.
Trial summary
This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial. The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Bimatoprost and Latanoprost/Timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Start not givento Dec 2004
- Phase
- Phase 3
- 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
- Patients diagnosed as having POAG (primary open-angle glaucoma) or ocular hypertension and 18 years or older who fulfilled the eligibility requirements detailed below and signed an informed consent at the screening visit were included.
- Two different groups of patients were potentially eligible:
- Those patients who were controlled (IOP< 21 mmHg) on the nonfixed combination of latanoprost and timolol (twice daily or once daily morning administration) for at least 3 months prior to the baseline visit.
- Patients on monotherapy either with latanoprost or timolol who were eligible for dual therapy being not satisfactorily controlled (IOP < 21 mmHg, or, as judged by the physician, target IOP was not reached).
- Pseudoexfoliation glaucomas and patients with diabetes were not excluded.
Who cannot join
- All patients in whom beta-blockers were contraindicated were excluded. Ocular Condition.
- Closed/barely open anterior chamber angles (ACAs) or history of acute angle closure. The ACA was viewed by means of the Goldmann 1-mirror lens. Shaffer grading was used, and grades II, III, and IV were included. Grades 0 and I were excluded.
- Ocular surgery or argon laser trabeculoplasty within the last 3 months.
- Ocular inflammation/infection occurring within 3 months before the pretrial visit.
- Neovascular glaucomas.
- Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
Show all 12Show fewer
- Other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement.
- Patients on either bimatoprost or the LTFC.
- Patients who had undergone refractive surgery. General
- Inability to adhere to treatment/visit plan.
- Participation in any other clinical trial (i.e., requiring in- formed consent) within 1 month before the prestudy visit. 11. Pregnancy, nursing, or, if applicable, nonuse of adequate contraception.
- 12. Any drug known to affect IOP.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Italy3 sites
Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari
Bari
A.O. San Paolo
Milan, Lombardy, 20142
Clinica Oculistica, Università degli studi di Roma, Tor Vergata
Rome
Germany2 sites
Universitaets-augenklinik
Dresden
Universitaets-augenklinik
Magdeburg
Greece2 sites
Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa
Larissa
II Department of Ophthalmology, Aristotle University of Thessaloniki
Thessaloniki
Switzerland1 site
Universitäts-Augenklinik, Inselspital, University of Bern
Bern
About this study
This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial.
The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol.
The main findings of the original trial had been published on Ophthalmology [2007;114: 2244-2251].
- Conditions
- Glaucoma
- Being tested
- Bimatoprost, Latanoprost/Timolol
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimatoprostDrug
Latanoprost/TimololDrug
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost | Experimental | once daily Receives: Drug: Bimatoprost |
| Latanoprost/Timolol | Experimental | once daily Receives: Drug: Latanoprost/Timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean diastolic and systolic perfusion pressures
The Primary outcome was the difference in mean diastolic and systolic perfusion pressures after bimatoprost and the LTFC
Measured: Baseline - Week 2 - Week 6 - Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fogagnolo, University of Milan
- Investigators
- Luca Rossetti, MD, Principal investigator, A.O. San Paolo Hospital Milan Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154217
- Sponsor's protocol ID
- LR-BLT
- Status last verified
- May 2014
- First submitted
- 21 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rossetti L, Karabatsas CH, Topouzis F, Vetrugno M, Centofanti M, Boehm A, Viswanathan A, Vorwerk C, Goldblum D. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on circadian intraocular pressure. Ophthalmology. 2007 Dec;114(12):2244-51. doi: 10.1016/j.ophtha.2007.01.025. Epub 2007 Apr 25.
PubMed 17459480Rossetti L, Sacchi M, Karabatsas CH, Topouzis F, Vetrugno M, Centofanti M, Boehm A, Vorwerk C, Goldblum D, Fogagnolo P. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on 24-hour blood and ocular perfusion pressures: the results of a randomized trial. BMC Ophthalmol. 2015 Jan 22;15:7. doi: 10.1186/1471-2415-15-7.
PubMed 25613811
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
- ClinicalTrials.gov ID
- NCT02154217
- Acronym / sponsor ID
- LR-BLT
- Conditions
- Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Primary completion
- Dec 2004 (actual)
- First posted
- 3 Jun 2014 (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.
This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial.
The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol.
The main findings of the original trial had been published on Ophthalmology [2007;114: 2244-2251].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost | Experimental | Drug: Bimatoprostonce daily |
| Latanoprost/Timolol | Experimental | Drug: Latanoprost/Timololonce daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed as having POAG (primary open-angle glaucoma) or ocular hypertension and 18 years or older who fulfilled the eligibility requirements detailed below and signed an informed consent at the screening visit were included.
- Those patients who were controlled (IOP< 21 mmHg) on the nonfixed combination of latanoprost and timolol (twice daily or once daily morning administration) for at least 3 months prior to the baseline visit.
- Patients on monotherapy either with latanoprost or timolol who were eligible for dual therapy being not satisfactorily controlled (IOP < 21 mmHg, or, as judged by the physician, target IOP was not reached).
- Pseudoexfoliation glaucomas and patients with diabetes were not excluded.
Key exclusion criteria (12 listed)
- All patients in whom beta-blockers were contraindicated were excluded. Ocular Condition.
- Closed/barely open anterior chamber angles (ACAs) or history of acute angle closure. The ACA was viewed by means of the Goldmann 1-mirror lens. Shaffer grading was used, and grades II, III, and IV were included. Grades 0 and I were excluded.
- Ocular surgery or argon laser trabeculoplasty within the last 3 months.
- Ocular inflammation/infection occurring within 3 months before the pretrial visit.
- Neovascular glaucomas.
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 | Drug | Bimatoprost |
| Latanoprost/Timolol | Drug | Latanoprost/Timolol |
Primary outcome
Difference in mean diastolic and systolic perfusion pressures
Time frame: Baseline - Week 2 - Week 6 - Week 12
The Primary outcome was the difference in mean diastolic and systolic perfusion pressures after bimatoprost and the LTFC
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 3 Jun 2014.
- Results publication: PubMed 17459480Rossetti L, Karabatsas CH, Topouzis F, Vetrugno M, Centofanti M, Boehm A, Viswanathan A, Vorwerk C, Goldblum D. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on circadian intraocular pressure. Ophthalmology. 2007 Dec;114(12):2244-51. doi: 10.1016/j.ophtha.2007.01.025. Epub 2007 Apr 25.
- Derived from this study: PubMed 25613811Rossetti L, Sacchi M, Karabatsas CH, Topouzis F, Vetrugno M, Centofanti M, Boehm A, Vorwerk C, Goldblum D, Fogagnolo P. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on 24-hour blood and ocular perfusion pressures: the results of a randomized trial. BMC Ophthalmol. 2015 Jan 22;15:7. doi: 10.1186/1471-2415-15-7.
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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.
Luca Rossetti, MD principal investigator
A.O. San Paolo Hospital Milan Italy
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimatoprost and Latanoprost/Timolol in people with Glaucoma, run by University of Milan at 9 sites in 5 countries.
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 5 inclusion and 12 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 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Germany, Greece, Switzerland, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Difference in mean diastolic and systolic perfusion pressures (time frame: Baseline - Week 2 - Week 6 - Week 12). 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 NCT02154217, which also lists 2 linked publications.
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 3 Jun 2014.