24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination
BTFC
A 3-month, 4-centre, Crossover, Double-masked Study Investigating the 24-hour Intraocular Pressure Control With the Bimatoprost/Timolol Fixed Combination Dosed Morning, or Evening in Subjects With Exfoliative Glaucoma
1 other identifier
interventional
60
1 country
2
Brief Summary
The objective of this crossover, randomized, placebo controlled, double-masked study is to compare the short-term (12 weeks) mean 24-hour IOP control and safety of the new fixed combination (bimatoprost/timolol, BTFC) given PM with placebo once in the morning, versus BTFC given AM with placebo once in the evening versus bimatoprost given in the evening in patients with exfoliative glaucoma (XFG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2007
2 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
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 13, 2007
CompletedFirst Posted
Study publicly available on registry
June 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedMay 12, 2014
May 1, 2014
1.2 years
June 13, 2007
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean 24-hour IOP
3 months of therapy
Secondary Outcomes (1)
Side effects with medications
3 months of therapy
Study Arms (2)
Bimatoprost/Timolol AM therapy
ACTIVE COMPARATORBimatoprost/Timolol PM therapy
ACTIVE COMPARATORInterventions
3-month chronic dosing in the morning
Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months
Eligibility Criteria
You may qualify if:
- The patient is suffering from XFG (if the patient has bilateral XFG, both eyes will be treated, but the worse eye will be selected for the statistical analysis)
- Patient is older than 39 years and younger than 85 years
- Patient is able and willing to participate in the study for the whole duration of the follow up. Will sign the consent form.
- At screening the untreated IOP at 10:00 (± 1 hr) is greater than 25 mm Hg and lower than 40 mm Hg
- After bimatoprost run-in therapy the treated IOP at 10:00 (± 1 hr) is greater than 19 mm Hg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Thessaloniki, 546 36, Greece
Glaucoma Unit, 1st University Dept of Ophthalmology
Thessaloniki, Greece
Related Publications (1)
Konstas AG, Hollo G, Mikropoulos D, Tsironi S, Haidich AB, Embeslidis T, Georgiadou I, Irkec M, Melamed S. Twenty-four-hour intraocular pressure control with bimatoprost and the bimatoprost/timolol fixed combination administered in the morning, or evening in exfoliative glaucoma. Br J Ophthalmol. 2010 Feb;94(2):209-13. doi: 10.1136/bjo.2008.155317. Epub 2009 Oct 12.
PMID: 19825835DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anastasios Konstas, MD, PhD
Head of the Glaucoma Unit
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Ophthalmology
Study Record Dates
First Submitted
June 13, 2007
First Posted
June 14, 2007
Study Start
March 1, 2007
Primary Completion
May 1, 2008
Study Completion
July 1, 2008
Last Updated
May 12, 2014
Record last verified: 2014-05