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

Primary Purpose

Eye Infections, Bacterial

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Azithromycin (T1225)
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Infections, Bacterial

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Unité de Pharmacologie Clinique

Outcomes

Primary Outcome Measures

Subjective ocular symptoms
Objective ocular symptoms

Secondary Outcome Measures

Systemic adverse events
Ocular adverse events
Ocular pharmacokinetic

Full Information

First Posted
July 25, 2006
Last Updated
July 26, 2006
Sponsor
Laboratoires Thea
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1. Study Identification

Unique Protocol Identification Number
NCT00357539
Brief Title
Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratoires Thea

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Infections, Bacterial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azithromycin (T1225)
Primary Outcome Measure Information:
Title
Subjective ocular symptoms
Title
Objective ocular symptoms
Secondary Outcome Measure Information:
Title
Systemic adverse events
Title
Ocular adverse events
Title
Ocular pharmacokinetic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude DUBRAY, Professor
Organizational Affiliation
Unité de Pharmacologie Clinique - Clermont-Ferrand (France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité de Pharmacologie Clinique
City
Clermont Ferrand
ZIP/Postal Code
63009
Country
France

12. IPD Sharing Statement

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

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