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

Condition(s) targeted: Ocular Hypertension; Open-angle Glaucoma

Intervention: Timolol and Tafluprost (Drug); Fixed Dose Combination of tafluprost and timolol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Santen Oy

Official(s) and/or principal investigator(s):
Auli Ropo, M.D., Study Director, Affiliation: Santen Oy
Clemens Vass, M.D., Principal Investigator, Affiliation: Medical University Vienna, Austria
Marieta Kostianeva, M.D., Principal Investigator, Affiliation: University Mulitiprofile Hospital for Active Treatment Sv.Georgi, Bulgaria
Eva Ruzickova, M.D., Principal Investigator, Affiliation: Vseobecna fakultni nemocnice v Praze, Czech Republic
Gábor Holló, Principal Investigator, Affiliation: Semmelweis Egyetem, Hungary
Guna Laganovska, M.D., Principal Investigator, Affiliation: P. Stradina Clinical University Hospital, Latvia
Maria L. Ribeiro, M.D., Principal Investigator, Affiliation: Aibili-Associação p/ Investigação Biomédica e Inovação em Luz e Imagem (AIBILI), Portugal
Julián García-Feijóo, M.D., Principal Investigator, Affiliation: Hospital Clinico San Carlos, Spain

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

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

Primary outcome: Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months

Secondary outcome:

Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months

Change from baseline in timewise IOPs

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Debrecen, Hungary

Starting date: March 2011
Last updated: June 7, 2012