Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
1 other identifier
interventional
200
5 countries
9
Brief 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 switched from a nonfixed combination of latanoprost and timolol. The main findings of the original trial had been published on Ophthalmology \[2007;114: 2244-2251\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
June 3, 2014
CompletedJune 3, 2014
May 1, 2014
May 21, 2014
May 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Baseline - Week 2 - Week 6 - Week 12
Study Arms (2)
Bimatoprost
EXPERIMENTALonce daily
Latanoprost/Timolol
EXPERIMENTALonce daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- \. Any drug known to affect IOP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Universitaets-augenklinik
Dresden, Germany
Universitaets-augenklinik
Magdeburg, Germany
Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa
Larissa, Greece
II Department of Ophthalmology, Aristotle University of Thessaloniki
Thessaloniki, Greece
A.O. San Paolo
Milan, Lombardy, 20142, Italy
Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari
Bari, Italy
Clinica Oculistica, Università degli studi di Roma, Tor Vergata
Rome, Italy
Universitäts-Augenklinik, Inselspital, University of Bern
Bern, Switzerland
Moorfields Eye Hospital,
London, United Kingdom
Related Publications (2)
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.
PMID: 17459480RESULTRossetti 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.
PMID: 25613811DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Rossetti, MD
A.O. San Paolo Hospital Milan Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 21, 2014
First Posted
June 3, 2014
Primary Completion
December 1, 2004
Last Updated
June 3, 2014
Record last verified: 2014-05