Pharmacokinetic study of glaucoma drug in cataract patients MedDRA version: 8.1 Level: LLT Classification code 10018304
Conditions
Interventions
Trade Name: Timosan 0.1% eye gel
Product Name: Timosan 0.1% eye gel
Pharmaceutical Form: Eye gel
INN or Proposed INN: timolol maleate
Concentration unit: % percent
Concentration type: equal
Concentrat
Sponsors
Santen Oy
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare corneal penetration of timolol into to the human aqueous humor after administration of 0.1% timolol eye gel or 0.5% aqueous timolol in patients scheduled for cataract surgery. Timolol concentrations in the aqueous humor will be measured. ;Primary end point(s): Concentration of timolol and timolol metabolites in aqueous humor at the time of cataract surgery. ;Secondary Objective: The metabolites of timolol will be analyzed from aqueous humor samples in order to find out indirect evidence that CYP2D6 mediated metabolism might be present in ocular tissues. In addition, metabolites of timolol will be analyzed from plasma samples of pilot patients. It will be investigated if the thickness of cornea and tear production has effects on the penetration of timolol into the human aqueous humor. | — |
Countries
Finland
Outcome results
None listed