- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154217
Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Dresden, Germany
- Universitaets-augenklinik
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Magdeburg, Germany
- Universitaets-augenklinik
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Larissa, Greece
- Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa
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Thessaloniki, Greece
- II Department of Ophthalmology, Aristotle University of Thessaloniki
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Bari, Italy
- Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari
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Rome, Italy
- Clinica Oculistica, Università degli studi di Roma, Tor Vergata
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Lombardy
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Milan, Lombardy, Italy, 20142
- A.O. san Paolo
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Bern, Switzerland
- Universitäts-Augenklinik, Inselspital, University of Bern
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London, United Kingdom
- Moorfields Eye Hospital,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Bimatoprost
once daily
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Experimental: Latanoprost/Timolol
once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in mean diastolic and systolic perfusion pressures
Time Frame: Baseline - Week 2 - Week 6 - Week 12
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The Primary outcome was the difference in mean diastolic and systolic perfusion pressures after bimatoprost and the LTFC
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Baseline - Week 2 - Week 6 - Week 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luca Rossetti, MD, A.O. San Paolo Hospital Milan Italy
Publications and helpful links
General 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.
- Rossetti 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.
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Glaucoma
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Timolol
- Bimatoprost
- Latanoprost
Other Study ID Numbers
- LR-BLT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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