Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol. This study will enroll patients who have ocular hypertension or glaucoma. The study schedule includes seven visits to the study site and three stages: washout of 5 days to 4 weeks depending on current glaucoma medication (if any) 6-month study treatment period 1-3 weeks post-study period

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 of Tafluprost and Timolol Eye Drops Given Concomitantly in Patients With Open Angle Glaucoma or Ocular Hypertension

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

Intervention / Treatment
-----------------
* Drug: Timolol and Tafluprost
* Drug: Fixed Dose Combination of tafluprost and timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or more A diagnosis of ocular hypertension or open-angle glaucoma Meet specific IOP level at visit 1 (screening)and visit 2 (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 greater than 36 mmHg at any time point at screening or baseline 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: Timolol and Tafluprost<br>Concomitant administration of preservative-free timolol and tafluprost eye drops | Drug: Timolol and Tafluprost<br>* Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months<br>|
| Experimental: Fixed Dose Combination of tafluprost and timolol<br>Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops | Drug: Fixed Dose Combination of tafluprost and timolol<br>* Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily. For masking purposes also: vehicle for timolol administered twice daily Treatment period 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months |  | 6 months | 

Secondary Outcome Measures

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