NCT01292460

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2011

Enrollment Period

1.6 years

First QC Date

February 8, 2011

Last Update Submit

March 12, 2013

Conditions

Ocular HypertensionOpen-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months

    At 3 months

Secondary Outcomes (2)

  • Change from baseline in average diurnal IOP

    At 2 and 6 weeks and 6 months

  • Change from baseline in timewise IOPs

    At 2 weeks, 6 weeks, 3 months and 6 months

Study Arms (4)

Preservative-free timolol

ACTIVE COMPARATOR
Drug: Timolol/ FDC/ Placebo/ Tafluprost

Preservative-free FDC and placebo

EXPERIMENTAL
Drug: Timolol/ FDC/ Placebo/ Tafluprost

Preservative-free tafluprost

ACTIVE COMPARATOR
Drug: Timolol/ FDC/ Placebo/ Tafluprost

Preservative-free FDC

EXPERIMENTAL
Drug: Timolol/ FDC/ Placebo/ Tafluprost

Interventions

Timolol/ FDC/ Placebo/ TafluprostDRUG

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).

Preservative-free FDCPreservative-free FDC and placeboPreservative-free tafluprostPreservative-free timolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eye clinic, University Hospital of Kuopio

Kuopio, 70210, Finland

Location

Eye Clinic, University Hospital of Oulu

Oulu, 90029 OYS, Finland

Location

Related Publications (1)

  • Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2.

    PMID: 25447269DERIVED

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Interventions

Timololtafluprost

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • Auli Ropo, M.D.

    Santen Oy

    STUDY DIRECTOR

  • Hannu Uusitalo, M.D., Prof.

    Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 9, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 13, 2013

Record last verified: 2011-03

Locations

FI(2)