Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops

June 7, 2012 updated by: Santen Oy

A Phase I, Randomized, Double-masked, 3-period Cross-over Clinical Study to Compare the Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops to Those of Preservative-free Tafluprost 0.0015% and Timolol 0.5% Eye Drops in Healthy Volunteers

The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70200
        • Kuopio University Hospital Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 45 years
  • Good general health
  • Meet best corrected ETDRS visual acuity

Exclusion Criteria:

  • Significant systemic or ocular disease
  • History of eye surgery, including refractive surgery
  • Allergy or hypersensitivity to study drug
  • Low heart rate (<50 bpm)
  • Clinically relevant low blood pressure
  • Asthma
  • Bradycardia
  • Use of contact lenses within one week prior to screening or during the study
  • Clinically significant obesity (body mass index > 30 kg/m2)
  • Blood donation within 2 months prior to screening
  • Females who are pregnant or lactating and females not using adequate contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tafluprost 0.0015%
Drug: Preservative free tafluprost 0.0015% eye drops
Preservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.
ACTIVE_COMPARATOR: Timolol 0.5%
Drug: Preservative free timolol 0.5% eye drops
Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days
EXPERIMENTAL: Fixed-dose combination of tafluprost 0.0015% and timolol 0.5%
Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops
Preservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
Time Frame: There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7
The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol.
There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
Time Frame: Day 1 and Day 7 of treatment periods I, II and III.

The changes from screening/baseline will be evaluated in following variables:visual acuity, IOP, biomicroscopy and ophthalmoscopy findings and drop discomfort.

Adverse events will be followed from screening to post-study visit.
Day 1 and Day 7 of treatment periods I, II and III.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (ESTIMATE)

September 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 7, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201150
  • 2011-001778-24 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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