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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306461
• Other study ID #: 201051
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2011
• Last updated: June 7, 2012
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Santen Oy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyLatvia: State Agency of MedicinesPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• Timolol and Tafluprost
Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months
• Fixed Dose Combination of tafluprost and timolol
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Oy

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months		6 months	No
Secondary	Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months		2 weeks, 6 weeks and 3 months	No
Secondary	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	No