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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ophthalmic Solutions
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
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014