Glaucoma de angulo abierto o hiperstensión ocular. Open-angle glaucoma or ocular hypertension MedDRA version: 9.1 Level: LLT Classification code 10030348 Term: Open angle glaucoma MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension
Conditions
Interventions
Trade Name: TRAVATAN 40 microgramos/ml, colirio en solución
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: TRAVOPROST
Other descriptive name: TRAVOPROST
Concentration unit: µl/ml microl
Sponsors
Alcon Research, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of either sex and any race, 50 years of age or older, diagnosed with open angle glaucoma (without pseudoexfoliation or pigment dispersion component) and require a trabeculectomy, who have dosed with TRAVATAN for at least 2 years or who have no (or less than 1 month) prior exposure to any topical, ocular prostaglandin analogue. 2. Only patients who satisfy all Informed Consent requirements may be included in the study. 3. Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study if they meet all of the following conditions: ?They are not pregnant and, ?They have a negative urine pregnancy test at the Screening Visit and, ?They are not breast-feeding and, ?They do not intend to become pregnant during the study period and, ?They are using highly effective birth control measures. 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. History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis). 2. History of or current ocular infection or ocular inflammation within the past 3 months in either eye. 3. History of intraocular surgical procedure. 4. History of a current clinically relevant progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. 5. History of ocular laser surgery as determined by subject history and/or examination. 6. Therapy with an investigational agent within 30 days prior to the Screening Visit. 7. History of or current evidence of severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study. 8. Additionally, the Alcon Medical Monitor may declare any subject ineligible for a valid medical reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pigmentation in the trabecular meshwork in subjects that have been treated for at least two years with TRAVATAN 0.004% compared to subjects without exposure (or < 1 month) to prostaglandine analogue.;Secondary Objective: No procede.;Primary end point(s): Primary: Assessment of the pigmentation of trabecular meshwork. Safety: Adverse Events | — |
Countries
Spain
Outcome results
None listed