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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01434888

Enrollment

Registered

2011-09-15

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2012-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

pharmacokinetics

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.

Interventions

DRUGPreservative free tafluprost 0.0015% eye drops

Preservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.

DRUGPreservative free timolol 0.5% eye drops

Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days

DRUGPreservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops

Preservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.	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

Measure	Time frame	Description
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.	The changes from screening/baseline will be evaluated in following variables:visual acuity, IOP, biomicroscopy and ophthalmoscopy findings and drop discomfort. Adverse events will be followed from screening to post-study visit.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026