24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination
Information source: Aristotle University Of Thessaloniki
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: Drug: bimatoprost/timolol fixed combination AM (Drug); Bimatoprost/timolol fixed combination dosed PM (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Aristotle University Of Thessaloniki Official(s) and/or principal investigator(s):
Anastasios Konstas, MD, PhD, Principal Investigator, Affiliation: Head of the Glaucoma Unit
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).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Mean 24-hour IOP
Secondary outcome: Side effects with medications
Detailed description:
PRIMARY STUDY OBJECTIVES
- To show that the mean 24-hour IOP control obtained with BTFC (morning or evening) is
statistically better to that with bimatoprost monotherapy given once on the evening.
- To demonstrate that the fixed combination will provide a significantly better IOP
control in the morning when dosed in the evening.
- To test whether the mean 24-hour IOP control obtained with BTFC given once in the
evening may be statistically better to that with BTFC given once in the morning.
- To show whether there will be less 24-hour fluctuation of IOP with the evening dosing
of BTFC.
STUDY POPULATION
Consecutive newly-diagnosed, or suitably washed-out patients with exfoliative glaucoma (XFG)
who exhibit a mean untreated IOP greater than 25 mm Hg at baseline (10: 00).
Eligibility
Minimum age: 39 Years.
Maximum age: 81 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Locations and Contacts
Glaucoma Unit, 1st University Department of Ophthalmology, Thessaloniki 546 36, Greece
Glaucoma Unit, 1st University Dept of Ophthalmology, Thessaloniki, Greece
Additional Information
Starting date: March 2007
Last updated: May 9, 2014
|
