Comparison between the effects on ocular pressure of Bimatoprost 0.01% and Timolol 0.5% during the day and night

• Conditions: glaucoma and ocular hypertension; MedDRA version: 14.1Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-024272-26-IT
• Lead Sponsor: IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Signed informed consent • Age> 18 years • Diagnosis of glauocoma or ocular hypertension. The definition of glaucoma or ocular hypertension is based on the guidelines of the 'European Glaucoma Society • Patients newly diagnosed (Ocular hypertension and glaucoma) and never treated with ocular hypotensive drugs with any value tonometer and patients with OHT and POAG in ocular hypotensive drug therapy alone and with IOP <22mmHg at the screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Inability to sign informed consent • Ocular conditions that can interfere with the results of the study • Narrow angle or a history of acute attacks of glaucoma • eye infection or inflammation in the 3 months preceding the screening visit • eye surgery, or argon laser trabeculoplasty in the last three months. • History of hypersensitivity to benzalkonium chloride or other components contained in the formulation of study drug • Use of topical drugs that may interfere with the study medication • Causes of secondary increase of intraocular pressure • Contraindications to the use of systemic drugs in the studio

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: evaluete: mean 24-hours IOP changes from baseline, IOP at each time point of the daily curve, mean day and night IOP, ocular hyperemia score, mean 24-hours systolic and diastolic blood pressure, mean 24-hours heart rate, incidence of adverse events, responses from questionnaire about drug tolerability and satisfaction;Primary end point(s): comparison between groups of the 24-hour mean IOP after 8 weeks of treatment;Timepoint(s) of evaluation of this end point: 5 months;Main Objective: to investigate the 24-hour IOP lowering efficacy and safety of Bimatoprost 0.01% administered once at night compared to Timolol 0.5% administered twice daily

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): mean 24-hours IOP changes from baseline, IOP at each time point of the daily curve, mean day and night IOP, ocular hyperemia score, mean 24-hours systolic and diastolic blood pressure, mean 24-hours heart rate, incidence of adverse events, responses from questionnaire about drug tolerability and satisfaction;Timepoint(s) of evaluation of this end point: 5 months