Clinical trial NCT01306461: Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Open-angle Glaucoma
Lead sponsor: Santen Oy
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months
timeFrame: 2 weeks, 6 weeks and 3 months
measure: Change from baseline in timewise IOPs
timeFrame: 2 weeks, 6 weeks, 3 months and 6 months
Other outcomes:
Locations:
city: Debrecen
country: Hungary
Study officials:
affiliation: Santen Oy
name: Auli Ropo, M.D.
role: STUDY_DIRECTOR
affiliation: Medical University Vienna, Austria
name: Clemens Vass, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Mulitiprofile Hospital for Active Treatment Sv.Georgi, Bulgaria
name: Marieta Kostianeva, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vseobecna fakultni nemocnice v Praze, Czech Republic
name: Eva Ruzickova, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis Egyetem, Hungary
name: Gábor Holló
role: PRINCIPAL_INVESTIGATOR
affiliation: P. Stradina Clinical University Hospital, Latvia
name: Guna Laganovska, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aibili-Associação p/ Investigação Biomédica e Inovação em Luz e Imagem (AIBILI), Portugal
name: Maria L. Ribeiro, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico San Carlos, Spain
name: Julián García-Feijóo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: