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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434888
• Other study ID #: 201150
• Secondary ID: 2011-001778-24
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2011
• Last updated: June 7, 2012
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: Santen Oy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Preservative 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.
• Preservative 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
• Preservative 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.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital Eye Clinic	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Santen Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.	The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol.	There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7	No
Secondary	Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.	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.	Day 1 and Day 7 of treatment periods I, II and III.	Yes