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

Phase 3

Completed

• Conditions: Glaucoma
• Interventions: Drug: Bimatoprost; Drug: Latanoprost/Timolol

• Registration Number: NCT02154217
• Lead Sponsor: University of Milan

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 \[2007;114: 2244-2251\].

Detailed Description

Not available

Study Timeline

• Primary Completion: 2004-12
• Status Verified: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-29
• Last Update Submitted: 2014-05-29
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

11. Any drug known to affect IOP.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimatoprost	Bimatoprost	once daily
Latanoprost/Timolol	Latanoprost/Timolol	once daily

Primary Outcome Measures

Name	Time	Method
Difference in mean diastolic and systolic perfusion pressures	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

Trial Locations

Locations (8)

Universitaets-augenklinik; 🇩🇪 Magdeburg, Germany

Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa; 🇬🇷 Larissa, Greece

A.O. San Paolo; 🇮🇹 Milan, Lombardy, Italy

II Department of Ophthalmology, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari; 🇮🇹 Bari, Italy

Clinica Oculistica, Università degli studi di Roma, Tor Vergata; 🇮🇹 Rome, Italy

Universitäts-Augenklinik, Inselspital, University of Bern; 🇨🇭 Bern, Switzerland

Moorfields Eye Hospital,; 🇬🇧 London, United Kingdom