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

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

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

Study Overview

• Status: Completed
• Conditions: Eye Infections, Bacterial
• Intervention / Treatment: Drug: Azithromycin (T1225)

Detailed Description

The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France, 63009
    • Unité de Pharmacologie Clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;
• Conjunctival hyperaemia score >= 2, watering score >= 2, folliculo-papillary conjunctivitis score >= 2, number of fluorescein-stained punctuations >= 10;
• Blepharitis, conjunctivitis, uveitis;
• Ocular laser treatment within the last 3 months;
• Ocular surgery, including LASIK and PRK, within the last 12 months;
• Topical ocular treatment during the last month;
• Ocular antibiotics within the last 7 days;
• Medication during the study (except paracetamol and contraceptives).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Subjective ocular symptoms
Objective ocular symptoms

Secondary Outcome Measures

Outcome Measure
Systemic adverse events
Ocular adverse events
Ocular pharmacokinetic

Collaborators and Investigators

• Sponsor: Laboratoires Thea
• Investigators: Principal Investigator: Claude DUBRAY, Professor, Unité de Pharmacologie Clinique - Clermont-Ferrand (France)

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Primary Completion: December 7, 2022
• Study Completion: March 1, 2002

Study Registration Dates

• First Submitted: July 25, 2006
• First Submitted That Met QC Criteria: July 26, 2006
• First Posted (Estimate): July 27, 2006

Study Record Updates

• Last Update Posted (Estimate): July 27, 2006
• Last Update Submitted That Met QC Criteria: July 26, 2006
• Last Verified: July 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections and Mycoses; Bacterial Infections; Eye Infections; Eye Infections, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: LT1225-PI1-09/01(F)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No