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Completed

NCT Number: NCT00356850

Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

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Key information

Conditions

Eye Infections, Bacterial Bacterial Infections Bacterial Infections and Mycoses Eye Diseases Eye Infections Infections

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male/female aged from 18 to 45 years;
  • Written informed consent;
  • Healthy volunteers without any subjective ocular symptom;
  • Corrected visual acuity >= 6/10;
  • Registered in the national register of healthy volunteers

Exclusion criteria

  • Ocular trauma, infection or inflammation within the last 3 months;
  • Conjunctival hyperaemia (score >= 2);
  • Folliculo-papillary conjunctivitis (score >= 2);
  • Topical ocular treatment within the last month;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Other ocular laser within the last 3 months;
  • Zithromax® and Azadose® within the last 3 months;
  • Medication during the study (except: paracetamol, contraceptives

Treatment and study plan

Azithromycin

Drug

Primary outcomes

  1. Area Under the Curve from 0 to 24 hours (AUC0-24h)

  2. Elimination half-life (t1/2)

  3. Maximum Concentration (Cmax)

  4. Concentration 24 hours after instillation (C24h)

Secondary outcomes

  1. Tolerance

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers

Important dates

Study start
2002
Study completion
2002
First posted
Jul 26, 2006
Registry last updated
Jul 26, 2006

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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