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

May 9, 2014 updated by: AGP Konstas, Aristotle University Of Thessaloniki

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 546 36
        • Glaucoma Unit, 1st University Department of Ophthalmology
      • Thessaloniki, Greece
        • Glaucoma Unit, 1st University Dept of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean 24-hour IOP
Time Frame: 3 months of therapy
3 months of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects with medications
Time Frame: 3 months of therapy
3 months of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Anastasios Konstas, MD, PhD, Head of the Glaucoma Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 13, 2007

First Submitted That Met QC Criteria

June 13, 2007

First Posted (Estimate)

June 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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