Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin. The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.

Official Title
-----------------
A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Ocular Hypertension, Open-angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Timolol/ FDC/ Placebo/ Tafluprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or more A diagnosis of ocular hypertension or open-angle glaucoma and prior use of timolol or prostaglandin. Meet specific IOP level at visit 1 (screening), visit 2 (run-in) and visit 3 (baseline). Meet specific visual acuity score Are willing to follow instructions Have provided a written informed consent Exclusion Criteria: Females who are pregnant, nursing or planning pregnancy IOP of 35 mmHg or greater Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse)or to wash-out medication brinzolamide Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening Use of contact lenses at Screening or during the study Presence of any abnormality or significant illness that could be expected to interfere with the patient safety or study parameters Current participation in another clinical trial within the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preservative-free timolol<br> | Drug: Timolol/ FDC/ Placebo/ Tafluprost<br>* Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).<br>|
| Experimental: Preservative-free FDC and placebo<br> | Drug: Timolol/ FDC/ Placebo/ Tafluprost<br>* Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).<br>|
| Active Comparator: Preservative-free tafluprost<br> | Drug: Timolol/ FDC/ Placebo/ Tafluprost<br>* Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).<br>|
| Experimental: Preservative-free FDC<br> | Drug: Timolol/ FDC/ Placebo/ Tafluprost<br>* Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months |  | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average diurnal IOP | Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months | At 2 and 6 weeks and 6 months | 
| Change from baseline in timewise IOPs | Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00) | At 2 weeks, 6 weeks, 3 months and 6 months |