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CompletedNCT01306461Updated Jun 8, 2012

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

A Phase 3 interventional study of Timolol and Tafluprost and Fixed Dose Combination of tafluprost and timolol in Ocular Hypertension and Open-angle Glaucoma, sponsored by Santen Oy. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-08.

Sponsored by Santen Oy · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
401
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Ocular Hypertension
  • Open-angle Glaucoma
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 401 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Santen Oy is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
401 participants (actual)

Study arms

  • Active comparator
    Timolol and Tafluprost

    Concomitant administration of preservative-free timolol and tafluprost eye drops

    Drug: Timolol and Tafluprost

  • Experimental
    Fixed Dose Combination of tafluprost and timolol

    Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops

    Drug: Fixed Dose Combination of tafluprost and timolol

Interventions

  • DrugTimolol and Tafluprost

    Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months

  • DrugFixed 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

06

What researchers measure

Primary outcomes

  1. Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 2 weeks, 6 weeks and 3 months

  2. 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

    Time frame: 2 weeks, 6 weeks, 3 months and 6 months

07

Study locations

1 site
  • Debrecen, Hungary
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01306461
Lead sponsor
Santen Oy
Responsible party
Sponsor
First posted
Mar 1, 2011
Start date
Mar 2011
Primary completion
Apr 2012
Completion
May 2012
Last update
Jun 8, 2012

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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