Open-Angle Glaucoma or Ocular Hypertension MedDRA version: 8.1 Level: PT Classification code 10030043 Term: Ocular hypertension
Conditions
Interventions
Trade Name: Travatan
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Travaprost
Other descriptive name: Travatan
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equ
Sponsors
Alcon Laboratories Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female of any ethnic origin; age equal or superior to 18 years with diagnosis of open-angle glaucoma or ocular hypertension; At Screening (Visit 0), patients must be uncontrolled on beta- blockers monotherapy (the mean IOP must be =19 mmHg at the 09:00 H measurement (plus/minus1 hour) in at least one eye, in sitting position); At baseline (Visit 1) patients must meet the following IOP entry criteria in the same eye assessed at the screening (Visit 0) : The mean IOP must be =19 to = 36 mmHg at the 09:00 H measurement (plus/minus1 hour) in sitting position; Visual acuity equal to or better than 20/200 (LogMAR 1.00); Patients willing and able to make required study visits; Written informed consent to participate in the study, by patient or legally representative; Non-ocludable angles in both eyes. 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 severe or serious hypersensitivity or contraindication to the study medications; Lactating or pregnant women, or women of childbearing potential without adequate contraception for the duration of the study; Patients taking systemic drugs or systemic disease that should influence the IOP stability; History of chronic or recurrent inflammatory eye disease; History of ocular trauma within the past six (6) months; History of clinically significant or progressive retinal disease; Intraocular surgery within the past six (6) months, as determined by patient history and/or examination; Ocular laser surgery within the past six (6) months, as determined by patient history and/or examination; Any form of glaucoma other than open-angle glaucoma or ocular hypertension; History of chronic or recurrent severe inflammatory eye disease (i.e. scleritis, uveitis); Unwillingness to accept minimal risk of iris or periocular color changes, or eyelash changes, potentially associated with the study medications; Presence of exfoliation glaucoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate fixed combination in patients with open-angle glaucoma or ocular hypertension. ;Secondary Objective: ;Primary end point(s): Change in mean IOP between baseline (Visit 1) and week 6 (Visit 3). | — |
Countries
Portugal
Outcome results
None listed