Randomized parallel-group, multicentre study to evaluate the after-use sensation and safety of carteolol LA 2% versus timolol LA 0.5% in simple intra-ocular hypertension and glaucoma.

• Conditions: Adult patients suffering from unilateral or bilateral ocular hypertension or POAG, IOP controlled with beta-blocker monotherapy (IOP < 21 mmHg and visual field stable); MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertension; MedDRA version: 9.1Level: LLTClassification code 10036719Term: Primary open angle glaucoma

• Registration Number: EUCTR2007-001680-30-PT
• Lead Sponsor: Bausch&Lomb Dr Gerhard Mann chem.-Fabrik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

•Adult patients, men or women
•Suffering from unilateral or bilateral ocular hypertension or POAG
•IOP controlled with beta-blocker monotherapy (IOP < 21mmHg and visual field stable)
•written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Age < 18 years
•IOP not controlled with beta-blocker monotherapy
•Angle closure, congenital and secondary glaucoma
•Any pathology contraindicating an IOP measurement
•Any intraocular infection or inflammation, ocular trauma, ocular surgery or laser trabeculoplasty within the previous 3 months
•Previous intolerance to carteolol or timolol, or to any other ingredients of the tested products
•Beta-blocker contraindications
•Ocular corticosteroids
•Contact lens wearers
•Severe systemic or ocular disease
• Hypotension
•Drug, alcohol abuse
•Involvement in the last 30 days in any other investigational drug study
•Expected change in treatment of concomitant disease
•Patients with a history of recurrent ocular herpes and/or recurrent uveitis.
•Change in ocular treatment within the last month.
•Patients treated with other topical ocular treatment within the last month
•Pregnant or lactating women.
•Women of child-bearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy.
•Patients for whom, in the physician's opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study.
•Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow up in the study period.
•Patients with neurotic, psychiatric disorders or suicidal tendencies

Study & Design

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