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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Oy
ClinicalTrials.gov Identifier:
NCT01434888
First received: September 12, 2011
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Preservative free tafluprost 0.0015% eye drops
Drug: Preservative free timolol 0.5% eye drops
Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Santen Oy:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 15
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434888

Locations
Finland
Kuopio University Hospital Eye Clinic
Kuopio, Finland, 70200
Sponsors and Collaborators
Santen Oy
  More Information

No publications provided

Responsible Party: Santen Oy
ClinicalTrials.gov Identifier: NCT01434888     History of Changes
Other Study ID Numbers: 201150, 2011-001778-24
Study First Received: September 12, 2011
Last Updated: June 7, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Santen Oy:
pharmacokinetics

Additional relevant MeSH terms:
Timolol
Tetrahydrozoline
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014