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24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination (BTFC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00486486
First received: June 13, 2007
Last updated: May 9, 2014
Last verified: May 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486486

Locations
Greece
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece, 546 36
Glaucoma Unit, 1st University Dept of Ophthalmology
Thessaloniki, Greece
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: May 9, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
24-hour IOP control

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension
Bimatoprost
Cloprostenol
Timolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014