Patient with glaucoma or ocular hypertension bilateral non controlled MedDRA version: 6.1 Level: HLGT Classification code 10018307
Conditions
Interventions
Trade Name: TRAVATAN*COLL. 1FL 40MCG/ML
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Travoprost
CAS Number: 157283-68-6
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
ALCON ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - written informed consent - male or female subjects aged 8805; 40 - bilateral primary open angle glaucoma or hypertension - intraocular pressure 19 mmHg at screening, at 8.00 a.m. - stability of optic nerve and field of vision damage in the last 6 months - washout of 6 weeks from possible topical treatments - visual acuity at correction best equal or better than 20/200 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: - history of any surgical intervention for glaucoma to the eye on study - history of any other surgical intervention to the eyes, laser-therapy, traumas or eye inflammation in the six months before the screening visit - history of ocular infections in the three weeks before the screening visit - corneal pathologies or any condition that could prevent a reliable IOP measurement - eye pathologies that could cause defects of the field of vision diabetic retinopathy, macular degeneration, neuropaty from compression of optic nerve - systemic hypertension not controlled by the therapy - instable systemic hypertension requiring frequent modifications of therapy - hypersensitivity to the components of the products under study - pregnant or breast-feeding women, or women with childbearing potential who do not accept to avoid pregnancy for the whole study duration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ND;Main Objective: To compare efficacy of concomitant administration of travoprost and brinzolamide vs fixed association dorzolamide-timololo on diurnal IOP in patients with glaucoma or ocular hypertension, by evaluating after 8 weeks of treatment -IOP baseline variation in mmHg - the area below the diurnal PIO curve mmHg-h measured from 8 00 a.m. to 8.00 p.m. every three hours To compare safety of concomitant administration of travoprost and brinzolamide vs fixed association dorzolamide-timololo; the following will be evaluated - the proportion of patients with adverse events - the incidence of adverse events;Primary end point(s): To compare efficacy of concomitant administration of travoprost and brinzolamide vs fixed association dorzolamide-timololo on diurnal IOP in patients with glaucoma or ocular hypertension, by evaluating after 8 weeks of treatment -IOP baseline variation in mmHg - the area below the diurnal PIO curve mmHg-h measured from 8 00 a.m. to 8.00 p.m. every three hours To compare safety of concomitant administration of travoprost and brinzolamide vs fixed association dorzolamide-timololo; the following will be evaluated - the proportion of patients with adverse events - the incidence of adverse events | — |
Countries
Italy
Outcome results
None listed