24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination (BTFC)
This study has been completed.
Sponsor:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00486486
First received: June 13, 2007
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: Drug: bimatoprost/timolol fixed combination AM Drug: Bimatoprost/timolol fixed combination dosed PM |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Aristotle University Of Thessaloniki:
Primary Outcome Measures:
- Mean 24-hour IOP [ Time Frame: 3 months of therapy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Side effects with medications [ Time Frame: 3 months of therapy ] [ Designated as safety issue: Yes ]
| Enrollment: | 60 |
| Study Start Date: | March 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Bimatoprost/Timolol AM therapy |
Drug: Drug: bimatoprost/timolol fixed combination AM
3-month chronic dosing in the morning
Drug: Bimatoprost/timolol fixed combination dosed PM
Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months
|
| Active Comparator: Bimatoprost/Timolol PM therapy |
Drug: Drug: bimatoprost/timolol fixed combination AM
3-month chronic dosing in the morning
Drug: Bimatoprost/timolol fixed combination dosed PM
Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months
|
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| Ages Eligible for Study: | 39 Years to 81 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486486
Locations
| Greece | |
| Glaucoma Unit, 1st University Dept of Ophthalmology | |
| Thessaloniki, Greece | |
| Glaucoma Unit, 1st University Department of Ophthalmology | |
| Thessaloniki, Greece, 546 36 | |
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
| Principal Investigator: | Anastasios Konstas, MD, PhD | Head of the Glaucoma Unit |
More Information
No publications provided by Aristotle University Of Thessaloniki
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki |
| ClinicalTrials.gov Identifier: | NCT00486486 History of Changes |
| Other Study ID Numbers: | A3241 |
| Study First Received: | June 13, 2007 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Aristotle University Of Thessaloniki:
|
24-hour IOP control |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Timolol Bimatoprost Cloprostenol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 19, 2013