Open angle glaucoma or ocular hypertension
Conditions
Interventions
Product Name: tafluprost 0.0015%, multidose
Product Code: AFP-168
Pharmaceutical Form: Eye drops, solution
Product Name: tafluprost 0.0015%, single dose
Product Code: AFP-168
Pharmaceutical Form: Eye
Sponsors
Santen Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 18 years or more - A diagnosis of open-angle glaucoma (primary open-angle glaucoma, capsular glaucoma or pigmentary glaucoma) or ocular hypertension - Prior use of prostaglandin(s) and a known positive treatment response to PGs (a 15% reduction in IOP confirmed in anamnesis) - An untreated (after washout) IOP of 22-34 mmHg in at least one eye at the 8:00 measurement at baseline (Visit 2) - A best corrected ETDRS visual acuity score of +0.6 logMAR or better in each eye - Willing to follow instructions and a written informed consent 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: - Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception - Previous participation in any clinical trial in which tafluprost was an investigational drug - Any uncontrolled systemic disease (e.g., hypertension, diabetes) - Filtration surgery or any other ocular (including ocular laser procedures) surgery within 6 months prior to Visit 1 (screening) in either eye - Change of an existing chronic therapy that could substantially effect the IOP or the study outcomes within 30 days prior to Visit 1 (screening), or anticipated change in such therapy during the study - IOP greater than 34 mmHg at any time point in any eye at Visit 2 (baseline) - Known allergy or hypersensitivity to the study medications or their components, including benzalkonium chloride (BAK) - Use of contact lenses at Visit 1 (screening) or during the study - Any active external ocular disease, inflammation, or infection of the eye and/or eyelids within 3 months from the Screening visit - Any ocular, systemic or psychiatric disease/condition that in the opinion of the investigator may put the patient at a significant risk or may confound the study results or may interefere significantly with the patient’s participation in the study - Any corneal abnormality or other condition preventing reliable applanation tonometry - Anterior chamber angle less than grade 2 according to Schaffer classification as measured by gonioscopy - Advanced visual field defect or a visual field defect that is anticipated to progress during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the pharmacodynamics (as expressed in IOP) of two formulations of tafluprost 0.0015% eyedrops (multidose = preserved and single dose = unpreserved) in patients with open-angle glaucoma or ocular hypertension. The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period (change from baseline in the overall diurnal IOP at 4 weeks). ;Primary end point(s): Primary Variable of pharmacodynamics : Change from baseline in the overall diurnal IOP at 4 weeks ;Secondary Objective: Analysis of safety variables (adverse events, visual acuity, ophthalmoscopy, biomicroscopy and visual field tests) Secondary pharmacodynamic variables: change from baseline in time-wise IOPs (8:00, 12:00, 16:00 and 20:00) at 4 weeks and change from baseline in the overall diurnal IOPs and timewise IOPs (8:00, 12:00, 16:00 and 20:00) at 1 week. | — |
Countries
Finland, Germany
Outcome results
None listed