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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154217
• Other study ID #: LR-BLT
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2014
• Last updated: May 29, 2014

Study information

• Verified date: May 2014
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Bimatoprost

• Latanoprost/Timolol

Locations

Country	Name	City	State
Germany	Universitaets-augenklinik	Dresden
Germany	Universitaets-augenklinik	Magdeburg
Greece	Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa	Larissa
Greece	II Department of Ophthalmology, Aristotle University of Thessaloniki	Thessaloniki
Italy	Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Universita` di Bari	Bari
Italy	A.O. San Paolo	Milan	Lombardy
Italy	Clinica Oculistica, Universita` degli studi di Roma, Tor Vergata	Rome
Switzerland	Universita¨ts-Augenklinik, Inselspital, University of Bern	Bern
United Kingdom	Moorfields Eye Hospital,	London

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Countries where clinical trial is conducted

Germany,  Greece,  Italy,  Switzerland,  United Kingdom, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline - Week 2 - Week 6 - Week 12	Yes