Corneal penetration of timolol into the human aqueous humor after administration of 0.1% Timosan eye gel or 0.5% timolol eye drops

• Conditions: Pharmacokinetic study of glaucoma drug in cataract patients; MedDRA version: 8.1Level: LLTClassification code 10018304

• Registration Number: EUCTR2006-001156-12-FI
• Lead Sponsor: Santen Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients of any race and either sex meeting all of the following criteria will be considered eligible for this study. The patients should
1.be 55-80 years
2.be in good general health
3.be scheduled for cataract surgery
4.provide a written informed consent

Are the trial subjects under 18?
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

Patients with any of the following conditions are not eligible for participation in this study:
1. patients with one sighted eye only
2. patients who have glaucoma
3. patients with previous surgical operation in the eye
4. known hypersensitivity to timolol or any component of the study medication, including the preservative benzalkonium chloride
5. use of any topical or systemic medication that could interfere with study medication
6. any corneal disorders
7. an active uveitis
8. heart rate < 50/min
9. contraindications to timolol treatment:
– bronchial asthma / history of bronchospasm
– history of bronchial asthma or severe obstructive pulmonary disease
– sinus bradycardia
– second or third degree AV block
– overt cardiac failure
– cardiogenic shock
– severe peripheral circulatory disturbance (Raynaud’s disease) and
peripheral disorders
– Prinzmetal’s angina
– untreated phaeochromocytoma
– hypotension
– corneal dystrophies
– severe allergic rhinitis and bronchial hyperreactivity
10. participation in another clinical trial involving an investigational drug/device, or participation in such trial within the last 30 days

Study & Design

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