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
2 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2011
CompletedFirst Posted
Study publicly available on registry
September 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 8, 2012
June 1, 2012
3 months
September 12, 2011
June 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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.
Study Arms (3)
Tafluprost 0.0015%
ACTIVE COMPARATORTimolol 0.5%
ACTIVE COMPARATORFixed-dose combination of tafluprost 0.0015% and timolol 0.5%
EXPERIMENTALInterventions
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 eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days
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.
Eligibility Criteria
You may qualify if:
- Aged 18 to 45 years
- Good general health
- Meet best corrected ETDRS visual acuity
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Santen Oylead
Study Sites (1)
Kuopio University Hospital Eye Clinic
Kuopio, 70200, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2011
First Posted
September 15, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
June 8, 2012
Record last verified: 2012-06