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

NCT01434888 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-06-08

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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.

DRUG

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

DRUG

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.

Sponsors & Collaborators

  • Santen Oy

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01434888 on ClinicalTrials.gov