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

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 Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292460
• Other study ID #: 201050
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2011
• Last updated: March 12, 2013
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2011
• Source: Santen Oy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyBelgium: Federal Agency for Medicinal Products and Health ProductsNetherlands: Medicines Evaluation Board (MEB)Israel: Ministry of HealthItaly: The Italian Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyEstonia: The State Agency of MedicineRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2012
• Est. primary completion date: September 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 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

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/ FDC/ Placebo/ Tafluprost
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).

Locations

Country	Name	City	State
Finland	Eye clinic, University Hospital of Kuopio	Kuopio
Finland	Eye Clinic, University Hospital of Oulu	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Santen Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months		At 3 months	No
Secondary	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	No
Secondary	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	No