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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 12, 2011
Last Updated Date	June 7, 2012
Start Date ^ICMJE	September 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01434888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 14, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Healthy Volunteers
Intervention ^ICMJE	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. 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 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.
Study Arm (s)	Active Comparator: Tafluprost 0.0015% Intervention: Drug: Preservative free tafluprost 0.0015% eye drops Active Comparator: Timolol 0.5% Intervention: Drug: Preservative free timolol 0.5% eye drops Experimental: Fixed-dose combination of tafluprost 0.0015% and timolol 0.5% Intervention: Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	15
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT01434888
Other Study ID Numbers ^ICMJE	201150, 2011-001778-24
Has Data Monitoring Committee	No
Responsible Party	Santen Oy
Study Sponsor ^ICMJE	Santen Oy
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Santen Oy
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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