Status:
COMPLETED
Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops
Lead Sponsor:
Santen Oy
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 pre...
Eligibility Criteria
Inclusion
- Aged 18 to 45 years
- Good general health
- Meet best corrected ETDRS visual acuity
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01434888
Start Date
September 1 2011
End Date
December 1 2011
Last Update
June 8 2012
Active Locations (1)
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1
Kuopio University Hospital Eye Clinic
Kuopio, Finland, 70200