Glaucoma andr ocular hypertension
Conditions
Interventions
Product Name: Bimatoprost
Pharmaceutical Form: Eye drops
INN or Proposed INN: BIMATOPROST
CAS Number: 155206-00-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentrat
Sponsors
Hospital Clinico San Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient diagnosis of primary open angle glaucoma or ocular hypertension with dispersion of pigment or exfoliation Intraocular pressure less than 30 mmHg 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Another form of glaucoma not mentioned History of allergy, hypersensibility or intolerance to any substance used in the trial Use of systemic medications that affect to the intraocular pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the effect in the ocular pressure of Bimatoprost pods in comparison with tafluprost pods;Secondary Objective: Determine the tolerability and the effect in the ocular surface of the Bimatoprost pods and compare with Tafluprost pods;Primary end point(s): Intraocular pressure at 9 am, 12 am and 3pm;Timepoint(s) of evaluation of this end point: At 2,6 an 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the Ocular surface disease index questionnaire Parameters of ocular surface (slit lamp and Schirmer's test);Timepoint(s) of evaluation of this end point: At 2,6 and 12 weeks | — |
Countries
Spain
Contacts
Public ContactRuben Sanchez jean
Hospital Clinico San Carlos
Outcome results
None listed