Patients with glaucoma open angle or glaucoma exfoliative with high risknewly diagnosed and untreated.
Conditions
Interventions
Trade Name: COMBIGAN COLLIRIO 5 ML
Product Name: COMBIGAN
Pharmaceutical Form: Eye drops
Trade Name: GANFORT 0,3 mg/ml + 5 mg/ml
Product Name: GANFORT
Pharmaceutical Form: Ear drops
Trade Name: LATA
Sponsors
AZIENDA OSPEDALIERA S. PAOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Newly diagnosed untreated patients; -Willingness to comply with the investigator’s and protocol’s instructions; ->21 years of age; -IOP equal to 27 mm Hg or more, at 10:00 am; -Early to moderate POAG or XFG, exhibiting a visual field damage between –5 dB and -12 dB; -High risk profile for progression. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - < 21 years of age; - On any medication that can interfere with study drugs; - Any comorbidity that could interfere with disease progress or VF reading; - Ocular surgery within last 6 months; - Pregnancy; - Allergic or intolerable to any components in study drugs; - Participating in any other study; - Inability to give informed consent; -Reactive airway disease, second or third degree heart block, poorly compensated congestive heart failure or concomitant use of systemic beta-blockers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare for the first time the quality of 24-hour IOP control obtained after 3 and 24 months of therapy with the combined administration of Combigan in the morning and Ganfort in the evening versus latanoprost administered once in the evening, in high risk newly diagnosed untreated patients with primary open-angle glaucoma (POAG), or exfoliative glaucoma (XFG) with IOP equal to or greater than 27 mm Hg and a visual field defect with an MD of at least -5 dB.;Secondary Objective: To identify the best long-term 24-hour IOP predictors for progression (e.g. determine the value of peak, mean or fluctuation of IOP over 24 hours). The study will correlate for the first time level of 24-hour IOP and progression rate, thus allowing the determination of a "safe" 24-hour IOP level with which nearly all at-risk XFG and POAG patients will not progress. The study will identify the long-term 24-hr IOP efficacy of the 2 selected therapeutic regimens in a group of at-risk glaucoma patients (high baseline IOP and POAG, or XFG). This study will demonstrate, for the first time, that early, effective 24-hour IOP lowering with fixed combination therapy can save sight years.;Primary end point(s): To compare for the first time the quality of 24-hour IOP control obtained after 3 and 24 months of therapy with the combined administration of Combigan in the morning and Ganfort in the evening versus latanoprost administered once in the evening, in high risk newly diagnosed untreated patients with primary open-angle glaucoma (POAG), or exfoliative glaucoma (XFG) with IOP equal to or greater than 27 mm Hg and a visual field defect with an MD of at least -5 dB.;Timepoint(s) of evaluation of this end point: 2 YEARS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To identify the best long-term 24-hour IOP predictors for progression (e.g. determine the value of peak, mean or fluctuation of IOP over 24 hours). The study will correlate for the first time level of 24-hour IOP and progression rate, thus allowing the determination of a "safe" 24-hour IOP level with which nearly all at-risk XFG and POAG patients will not progress. ;Timepoint(s) of evaluation of this end point: 2 YEARS | — |
Countries
Italy
Contacts
Public ContactDirector of ophthalmology
AZIENDA OSPEDALIERA SAN PAOLO
Outcome results
None listed