Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops

Santen

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops

Drug: Preservative free tafluprost 0.0015% eye drops

Drug: Preservative free timolol 0.5% eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT01434888

201150

2011-001778-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts 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