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NCT Number: NCT00879099

Interaction Study of Timolol Eye Drops and Paroxetine Capsules

The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma levels of timolol and its main metabolites after topical application of ophthalmic timolol products.

This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy male volunteers aged 18 - 40 years will be enrolled.

Placebo or paroxetine will be given for three days after which 1 drop of timolol product will be administered once in both eyes.

The duration of the paroxetine or placebo treatment period will be 3 days. There will be four different treatment periods. A washout between the study periods will be at least 4 weeks.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Helsinki, Department of Clinical Pharmacology

Helsinki, Biomedicum, 00014, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • male
  • 18 - 40 years of age
  • be in good general health
  • be willing to follow instructions
  • provide a written informed consent
  • have a BMI of 18.5 - 26
  • have systolic blood pressure at least 105 mmHg
  • have haemoglobin at least 135 g/l.

Exclusion criteria

  • known hypersensitivity to timolol, paroxetine or any component of the study medications
  • any contraindications to timolol treatment including asthma and obstructive lung disease
  • any contraindications to paroxetine treatment
  • have heart rate 50/min or less in rest
  • any regular medication
  • allergy requiring antihistamine or ocular or nasal treatment
  • clinically significant abnormalities (from normal limits) in laboratory values: basic blood count, creatinine, ALAT, AFOS, gamma-GT, K, Na
  • clinically significant EKG abnormalities assessed by the investigator
  • blood donation within the last 60 days (the required time period between two donations for men given by RedCross Finland).
  • participation in another clinical trial involving an investigational drug/device, or participation in such trial within the last 60 days

Treatment and study plan

paroxetine

Drug

Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.

Placebo

Drug

Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.

timolol maleate

Drug

Oftan Timolol 0,5 % eye drop. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.

Primary outcomes

  1. The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax).

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Santen Oy

Industry

Registry information

Official study title

The Effect of Paroxetine on the Plasma Levels of Timolol Using Ophthalmic 0.5% Timolol Eye Drops and 0.1% Timolol Eye Gel in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 9, 2009
Registry last updated
Jan 28, 2010

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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