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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Azithromycin (T1225)

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

NCT ID

NCT00357539

First Posted

July 25, 2006

Last Updated

July 26, 2006

Sponsor

Laboratoires Thea

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

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

Eye Infections, Bacterial

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial