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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Santen Oy
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
Overview
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 preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Tafluprost 0.0015%
Intervention: Preservative free tafluprost 0.0015% eye drops (Drug)
Timolol 0.5%
Intervention: Preservative free timolol 0.5% eye drops (Drug)
Fixed-dose combination of tafluprost 0.0015% and timolol 0.5%
Intervention: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops (Drug)
Outcomes
Primary Outcomes
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
The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol.
Secondary Outcomes
- Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.(Day 1 and Day 7 of treatment periods I, II and III.)