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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Preservative free tafluprost 0.0015% eye drops; Drug: Preservative free timolol 0.5% eye drops; Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops

• Registration Number: NCT01434888
• Lead Sponsor: Santen Oy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-09-14
• Study First Posted: 2011-09-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Aged 18 to 45 years
• Good general health
• Meet best corrected ETDRS visual acuity

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tafluprost 0.0015%	Preservative free tafluprost 0.0015% eye drops	-
Timolol 0.5%	Preservative free timolol 0.5% eye drops	-
Fixed-dose combination of tafluprost 0.0015% and timolol 0.5%	Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kuopio University Hospital Eye Clinic; 🇫🇮 Kuopio, Finland