Open angle glaucoma or ocular hypertension
Conditions
Interventions
Product Name: Tafluprost 0.0015 mg/ml, multidose
Product Code: AFP-168
Pharmaceutical Form: Eye drops, solution
Pharmaceutical form of the placebo: Eye drops, solution
Route of administration of the p
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 • An IOP of 22-30 mmHg at the screening visit with monotherapy other than prostaglandins • An IOP of 22-30 mmHg in at least one eye in at least one measurement of the diurnal IOP curve (at 8:00, 10:00 and 16:00) at the baseline visit (Visit 2) while having used timolol 0.5% eye drops twice daily as the only glaucoma medication for at least 4 weeks. • A best corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20/80) or better in each eye • Are willing to follow instructions • Have provided 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 without time limit or any other ocular (including ocular laser procedures) surgery within 6 months prior to Visit 1 in the treated eye(s) • Clinically relevant low or high heart rate or blood pressure for age, or contraindications to beta-blocker therapy such as chronic obstructive pulmonary disease, bronchial asthma, greater than first degree heart block, and uncontrolled congestive heart failure • Change of an existing chronic therapy that could substantially effect the IOP or the study outcomes within 30 days prior to Visit 1, or anticipated change in such therapy during the study • IOP greater than 30 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 or during the study • Any active external ocular disease, inflammation, or infection of the eye and/or eyelids within 3 months from study start • Any ocular 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 • Use of any other antiglaucoma medications than the study medications during the study • Current alcohol or drug abuse • Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the efficacy and safety of tafluprost 0.0015% eye drops when used as adjunctive therapy to timolol 0.5% eye drops in open-angle glaucoma or ocular hypertension patients who are only partially controlled with timolol treatment. Primary efficacy variable A repeated measurements analysis of covariance (RM ANCOVA) model will be used to analyse the changes from baseline in the diurnal IOP at 2, 4 and 6 weeks. The model will include fixed effects for center, baseline, treatment, visit and time, and all interactions among treatment, visit and time. The difference (tafluprost vs. vehicle) at 6 weeks and a 95% confidence interval for the difference will be estimated from the RM ANCOVA model using a contrast (over all three time points). The model will be fitted using the Mixed procedure in SAS. ;Secondary Objective: Analysis of safety Secondary efficacy variables The overall IOP comparisons at 2 and 4 weeks and the time-wise (i.e. 8:00, 10:00 and 16:00) IOP comparisons at 2, 4 and 6 weeks will be done using contrasts in the RM ANCOVA model described above. The (cumulative) distribution of responders at 6 weeks will be characterized descriptively and graphically. Statistical tests, e.g. a Cochran-Mantel-Haenszel test stratified by center (CMH), may be used to illustrate the comparability of the two treatment groups. In addition, absolute IOP values will be summarised descriptively. ;Primary end point(s): Changes from baseline in the diurnal IOP at 2, 4 and 6 weeks | — |
Countries
Estonia, Latvia
Outcome results
None listed