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

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Bimatoprost

Latanoprost/Timolol

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.
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.

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.
Ocular surgery or argon laser trabeculoplasty within the last 3 months.
Ocular inflammation/infection occurring within 3 months before the pretrial visit.
Neovascular glaucomas.
Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
Other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement.
Patients on either bimatoprost or the LTFC.
Patients who had undergone refractive surgery. General
Inability to adhere to treatment/visit plan.
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.

Sites / Locations

Universitaets-augenklinik
Universitaets-augenklinik
Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa
II Department of Ophthalmology, Aristotle University of Thessaloniki
A.O. San Paolo
Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari
Clinica Oculistica, Università degli studi di Roma, Tor Vergata
Universitäts-Augenklinik, Inselspital, University of Bern
Moorfields Eye Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Bimatoprost

Latanoprost/Timolol

Arm Description

once daily

Outcomes

Primary Outcome Measures

Difference in mean diastolic and systolic perfusion pressures

The Primary outcome was the difference in mean diastolic and systolic perfusion pressures after bimatoprost and the LTFC

Secondary Outcome Measures

Full Information

NCT ID

NCT02154217

First Posted

May 21, 2014

Last Updated

May 29, 2014

Sponsor

University of Milan

1. Study Identification

Unique Protocol Identification Number

NCT02154217

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Milan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bimatoprost

Arm Type

Experimental

Arm Description

once daily

Arm Title

Latanoprost/Timolol

Arm Type

Experimental

Arm Description

once daily

Intervention Type

Drug

Intervention Name(s)

Bimatoprost

Intervention Type

Drug

Intervention Name(s)

Latanoprost/Timolol

Primary Outcome Measure Information:

Title

Difference in mean diastolic and systolic perfusion pressures

Description

The Primary outcome was the difference in mean diastolic and systolic perfusion pressures after bimatoprost and the LTFC

Time Frame

Baseline - Week 2 - Week 6 - Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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. 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. Ocular surgery or argon laser trabeculoplasty within the last 3 months. Ocular inflammation/infection occurring within 3 months before the pretrial visit. Neovascular glaucomas. Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions. Other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement. Patients on either bimatoprost or the LTFC. Patients who had undergone refractive surgery. General Inability to adhere to treatment/visit plan. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luca Rossetti, MD

Organizational Affiliation

A.O. San Paolo Hospital Milan Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitaets-augenklinik

City

Dresden

Country

Germany

Facility Name

Universitaets-augenklinik

City

Magdeburg

Country

Germany

Facility Name

Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa

City

Larissa

Country

Greece

Facility Name

II Department of Ophthalmology, Aristotle University of Thessaloniki

City

Thessaloniki

Country

Greece

Facility Name

A.O. San Paolo

City

Milan

State/Province

Lombardy

ZIP/Postal Code

20142

Country

Italy

Facility Name

Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari

City

Bari

Country

Italy

Facility Name

Clinica Oculistica, Università degli studi di Roma, Tor Vergata

City

Rome

Country

Italy

Facility Name

Universitäts-Augenklinik, Inselspital, University of Bern

City

Bern

Country

Switzerland

Facility Name

Moorfields Eye Hospital,

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

17459480

Citation

Rossetti L, Karabatsas CH, Topouzis F, Vetrugno M, Centofanti M, Boehm A, Viswanathan A, Vorwerk C, Goldblum D. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on circadian intraocular pressure. Ophthalmology. 2007 Dec;114(12):2244-51. doi: 10.1016/j.ophtha.2007.01.025. Epub 2007 Apr 25.

Results Reference

result

PubMed Identifier

25613811

Citation

Rossetti L, Sacchi M, Karabatsas CH, Topouzis F, Vetrugno M, Centofanti M, Boehm A, Vorwerk C, Goldblum D, Fogagnolo P. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on 24-hour blood and ocular perfusion pressures: the results of a randomized trial. BMC Ophthalmol. 2015 Jan 22;15:7. doi: 10.1186/1471-2415-15-7.

Results Reference

derived

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

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