Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops
Information source: Santen Oy
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: 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 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Santen Oy
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Primary outcome: Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
Secondary outcome: Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Kuopio University Hospital Eye Clinic, Kuopio 70200, Finland
Additional Information
Starting date: September 2011
Last updated: June 7, 2012
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