Primary open angle glaucoma or ocular hypertensive patients, any level of intraocular pressure. MedDRA version: 9.1 Level: PT Classification code 10030348
Conditions
Interventions
Trade Name: GANFORT
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: TIMOLOLO MALEATO
CAS Number: 26921-17-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Co
Sponsors
Prof. Stefano Gandolfi-Universita` degli studi di Parma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosis of poag and oh (at least in one eye) 2.patient on therapy with timolol 0.5% for at least 3 months 3.patient who has not reached the target iop as determined by the treating physician 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
Exclusion criteria: 1.Age < 18 years 2.Beta blockers are contraindicated 3.Ocular condition that are of safety concern and that can interfere with the study results 4.Closed/barely open anterior chamber angles or history of acute angle closure 5.Ocular surgery or argon laser trabeculoplasty within the last three months 6.Ocular inflammation/infection occurring within three months prior to pre-trial visit 7.Neurovascular patients (including diabetic patients with neovascular glaucoma) 8.Concominant topical ocular medication that can interfere with study medication 9.Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions 10.Other abnormal condition or symptom preventing the patient from entering the trial, according to the investigator`s judgement 11.refractive surgery patients 12.women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing 13.Inability to adhere to treatment/visit plan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and efficacy of a prosta-timolol fixed combination with a cai-timolol fixed combination in patients already on beta-blockers monotherapy;Secondary Objective: Area-under curve (intraocular pressure - IOP);Primary end point(s): Intraocular pressure (diurnal phasing 8-12-16) | — |
Countries
Italy
Outcome results
None listed