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Completed

NCT Number: NCT01434888

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kuopio University Hospital Eye Clinic

Kuopio, 70200, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preservative free tafluprost 0.0015% eye drops

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.

    Time frame: 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 outcomes

  1. Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Santen Oy

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2011
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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