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

September 12, 2011
June 7, 2012
September 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01434888 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01434888
201150, 2011-001778-24
No
Santen Oy
Santen Oy
Not Provided
Not Provided
Santen Oy
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP