Patients diagnosed with ocular hypertension or open-angle glaucoma (primary open-angle glaucoma [POAG], capsular glaucoma or pigmentary glaucoma). MedDRA version: 12.1 Level: LLT Classification code 10030043 Term: Ocular hypertension MedDRA version: 12.1 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma MedDRA version: 12.1 Level: LLT Classification code 10035015 Term: Pigmentary glaucoma MedDRA version: 12.1 Level: LLT Classification code 10037118 Term: Pseudoexfolia
Conditions
Interventions
Product Name: Preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5%
Product Code: FDC
Pharmaceutical Form: Eye drops, solution
Current Sponsor code: DE-111A
Other descriptiv
Sponsors
Santen Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of any race and either sex meeting all of the following criteria: 1. Aged 18 years or more 2. A diagnosis of ocular hypertension or open-angle glaucoma (either POAG, capsular glaucoma or pigmentary glaucoma) in one or both eyes 3. Clinical need for additional IOP lowering medication as judged by the investigator and an untreated (after washout if applicable) IOP of =23 mmHg at the 8:00 measurement at baseline in one or both eyes 4. Patients on prior glaucoma medication must have following minimum washout: • =4 weeks for ß-adrenergic antagonists (ß-blockers) • =4 weeks for prostamides or prostaglandin analogues • =3 weeks for a-adrenergic agonists (a-agonists) • =7 days for carbonic anhydrase inhibitors (CAIs) • =5 days for miotics 5. A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes (i.e. monocular patients are not eligible) 6. Are willing to follow instructions 7. 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: 1. Females who are pregnant, nursing or planning pregnancy, or females of childbearing potential who are not using a reliable method of contraception 2. Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy 3. Any corneal abnormality or other condition preventing reliable applanation tonometry in the treated eyes, including prior refractive eye surgery 4. IOP greater than 36 mmHg at any time point in either eye at Screening or Baseline visits 5. Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye 6. Suspected contraindication to tafluprost or timolol therapy; a. hypersensitivity to tafluprost/timolol or any of the excipients b. low heart rate of <50 bpm (at Screening visit) or clinically relevant low blood pressure for age, chronic obstructive pulmonary disease, bronchial asthma, strong tendency to bronchospasm, certain cardiac arrhythmias, the most common of which are second or third degree AV block and bradycardia, or uncontrolled congestive heart failure c. also for washout medication Azopt® (use of which is judged by the investigator): hypersensitivity to brinzolamide or any of the excipients, known hypersensitivity to sulphonamide, severe renal insufficiency or hyperchloraemic acidosis 7. Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening in eye(s) to be treated with study medication 8. Use of contact lenses at Screening or during the study 9. Advanced visual field defect in either eye or anticipated progression during the study as judged by the investigator 10. Inability to safely discontinue the use of ocular hypotensive medications during the washout period 11. Any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule or anterior chamber lenses, known risk factors for cystoid macular oedema or iritis/uveitis), systemic or psychiatric disease/condition (e.g. uncontrolled arterial hypertension, diabetes) that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient’s participation in the study as judged by the investigator 12. Change of an existing chronic therapy that could substantially affect the IOP or the study outcomes within 30 days prior to Visit 1, or anticipated change in such therapy during the study 13. Current alcohol or drug abuse 14. 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 compare the efficacy and safety of the preservative-free FDC of tafluprost 0.0015% and timolol 0.5% eye drops to concomitant administration of preservative-free tafluprost 0.0015% and preservative-free timolol 0.5%. Primary Efficacy Variable: o Change from baseline in the average diurnal IOP at 6 months The primary objective of the study is to demonstrate that after a 6-month treatment period the preservative-free FDC administered once daily is non-inferior to concomitant administration of tafluprost 0.0015% once daily and timolol 0.5% twice daily in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).;Secondary Objective: Secondary Efficacy Variables o Proportion of responders (e.g. a decrease of IOP of 20% or more or an IOP level of 16 mmHg or less) at 6 months o Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 3 months o Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00) at 2 weeks, 6 weeks, 3 months and 6 months Evaluation of safety and tolerability of the FDC vs concomitant administration of tafluprost and timolol: o Adverse events o Visual acuity o Central corneal thickness o Conjunctival redness o Biomicroscopy o Ophthalmoscopy o Visual field examination o Resting blood pressure and heart rate o Overall drop discomfort ;Primary end point(s): Change from baseline in the average diurnal intraocular pressure (IOP) at 6 months. Diurnal IOP measurements will be performed at 8:00 (+/- 1 h), 10:00 (+/- 1 h) and 16:00 (+/- 1 h) The primary evaluation of IOP will be based on the worse eye. | — |
Countries
Austria, Bulgaria, Czech Republic, Latvia, Portugal, Spain
Outcome results
None listed