Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures

May 29, 2014 updated by: Paolo Fogagnolo, University of Milan

This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial.

The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol.

The main findings of the original trial had been published on Ophthalmology [2007;114: 2244-2251].

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

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

      • Dresden, Germany
        • Universitaets-augenklinik
      • Magdeburg, Germany
        • Universitaets-augenklinik
      • Larissa, Greece
        • Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa
      • Thessaloniki, Greece
        • II Department of Ophthalmology, Aristotle University of Thessaloniki
      • Bari, Italy
        • Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari
      • Rome, Italy
        • Clinica Oculistica, Università degli studi di Roma, Tor Vergata
    • Lombardy
      • Milan, Lombardy, Italy, 20142
        • A.O. san Paolo
      • Bern, Switzerland
        • Universitäts-Augenklinik, Inselspital, University of Bern
      • London, United Kingdom
        • Moorfields Eye Hospital,

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients diagnosed as having POAG (primary open-angle glaucoma) or ocular hypertension and 18 years or older who fulfilled the eligibility requirements detailed below and signed an informed consent at the screening visit were included.

Two different groups of patients were potentially eligible:

  1. Those patients who were controlled (IOP< 21 mmHg) on the nonfixed combination of latanoprost and timolol (twice daily or once daily morning administration) for at least 3 months prior to the baseline visit.
  2. Patients on monotherapy either with latanoprost or timolol who were eligible for dual therapy being not satisfactorily controlled (IOP < 21 mmHg, or, as judged by the physician, target IOP was not reached).

Pseudoexfoliation glaucomas and patients with diabetes were not excluded.

Exclusion Criteria:

All patients in whom beta-blockers were contraindicated were excluded. Ocular Condition.

  1. Closed/barely open anterior chamber angles (ACAs) or history of acute angle closure. The ACA was viewed by means of the Goldmann 1-mirror lens. Shaffer grading was used, and grades II, III, and IV were included. Grades 0 and I were excluded.
  2. Ocular surgery or argon laser trabeculoplasty within the last 3 months.
  3. Ocular inflammation/infection occurring within 3 months before the pretrial visit.
  4. Neovascular glaucomas.
  5. Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
  6. Other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement.
  7. Patients on either bimatoprost or the LTFC.
  8. Patients who had undergone refractive surgery. General
  9. Inability to adhere to treatment/visit plan.
  10. Participation in any other clinical trial (i.e., requiring in- formed consent) within 1 month before the prestudy visit. 11. Pregnancy, nursing, or, if applicable, nonuse of adequate contraception.

12. Any drug known to affect IOP.

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bimatoprost
once daily
Experimental: Latanoprost/Timolol
once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean diastolic and systolic perfusion pressures
Time Frame: Baseline - Week 2 - Week 6 - Week 12
The Primary outcome was the difference in mean diastolic and systolic perfusion pressures after bimatoprost and the LTFC
Baseline - Week 2 - Week 6 - Week 12

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Luca Rossetti, MD, A.O. San Paolo Hospital Milan Italy

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.

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

Primary Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

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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