Prospective, multicentric, double-masked clinical study to compare the efficacy and safety of Ganfort and Duotrav in primary open angle and pseudoexfoliative glaucoma patients previously treated with Xalacom - ND
- Conditions
- GlaucomaMedDRA version: 9.1Level: LLTClassification code 10018304Term: Glaucoma
- Registration Number
- EUCTR2007-004023-38-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
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 124
The patient is suffering from POAG or PEX (If the patient has glaucoma and high IOP in both eyes, both eyes will be treated but the worst eye chose for the statistical analysis). Glaucoma definition is based on the European Glaucoma Society Guidelines. The patient is on either a non-fixed combination of Xalatan and Timolol for at least 3 months or on Xalacom for at least 6 month The patient has an IOP<21 mm Hg at the 8am time point.. The patient has not reached the target IOP as set 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
Not at least 18 years old Beta blockers are contraindicated Closed/barely open anterior chamber angles or history of acute angle closure. Ocular surgery or argon laser trabeculoplasty within the last three months. Ocular inflammation/infection occurring within three months prior to pre-trial visit. Concominant topical ocular medication that can interfere with study medication Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions. Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method