Interaction Study of Timolol Eye Drops and Paroxetine Capsules

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00879099

Enrollment

Registered

2009-04-09

Start date

2009-04-30

Completion date

2010-01-31

Last updated

2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Interaction, healthy volunteers, Interaction study for healthy volunteers

Brief summary

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.

Interventions

DRUGParoxetine

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

DRUGPlacebo

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

DRUGtimolol maleate

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026