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OpenTrials
Completed

NCT Number: NCT00357292

Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers

To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation

Completed

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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 the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female aged from 18 to 45 years old;
  • Written informed consent;
  • Healthy volunteers (without any ocular symptom);
  • Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - Slit lamp examination without clinical relevant abnormalities - Tear break-up time (BUT) ≥10 seconds - Lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - Lissamine green test total score < 4 +).

Exclusion criteria

  • Ocular trauma, infection or inflammation within the last 3 months;
  • Blepharitis;
  • Conjunctival hyperaemia (score >= 2 +);
  • Watering (score >= 2);
  • Contact lenses;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Topical ocular treatment within the last month;
  • Systemic antibiotics within the last 7 days;
  • Any medication during the study (except: Paracetamol and contraceptives).

Treatment and study plan

Azithromycin (T1225)

Drug

Primary outcomes

  1. Ocular subjective symptoms

  2. Ocular objective symptoms

Secondary outcomes

  1. Ocular pharmacokinetic.

  2. Ocular and systemic adverse events.

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

Important dates

Study start
2002
Study completion
2002
First posted
Jul 27, 2006
Registry last updated
Jul 27, 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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