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.

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