24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice

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

24-Hour Intraocular Pressure Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma

The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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
        • Glaucoma Unit, 1st University Department 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

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years
  • Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye
  • Study patients should have mild to moderate exfoliative glaucoma (VF loss <12 dB; cupping 0.8 or less)
  • Patient with exfoliation syndrome should fulfill the IOP criterion (IOP > 29 mm Hg at 10:00)
  • Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP
  • Patient agrees to be treated for at least 3 months with latanoprost and bimatoprost/timolol fixed combination drops dosed in the evening
  • In study eye distance best corrected Snelen visual acuity greater than 1/10

Exclusion Criteria:

  • Contraindications to therapy with latanoprost, bimatoprost, or β-blockers
  • History of non-adherence or previously recorded evidence of lack of response (<10% morning IOP reduction) to any antiglaucoma medication
  • Patient can not understand the instructions and adhere to medications
  • Patient is a female of childbearing potential or lactating mother
  • Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Signs of ocular infection, except blepharitis, or corneal abnormality that may affect IOP measurements
  • The other eye can not receive the same therapy, or remain without medical therapy
  • Closed angles

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 drops
The patients will be treated with bimatoprost/timolol fixed combination therapy
Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Administered once in the evening
Other Names:
  • Xalatan
  • Ganfort
Drug: Latanoprost, 24-hour intraocular pressure monitoring
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
Other Names:
  • Xalatan
  • Ganfort
Active Comparator: Latanoprost drops
The patients will be crossed over to therapy with latanoprost
Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Administered once in the evening
Other Names:
  • Xalatan
  • Ganfort
Drug: Latanoprost, 24-hour intraocular pressure monitoring
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
Other Names:
  • Xalatan
  • Ganfort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour IOP reduction between the two medications
Time Frame: 3 months
Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg).
3 months

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 G Konstas, MD, PhD, Glaucoma Unit, 1st University Department of Ophthalmology

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

April 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5134

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.

Clinical Trials on Glaucoma

Clinical Trials on Bimatoprost/Timolol, 24-hour intraocular pressure monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe