Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Back to results

Primary Purpose

Status

Completed

Phase

Phase 1

Locations

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 subjective ocular symptom; Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4); Registered, or agreed to be registered, in the national register of healthy volunteers Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months; number of corneal stained punctuations >= 5; blepharitis, conjunctivitis, uveitis; contact lenses; topical ocular treatment within the last month; ocular laser within the last 3 months; ocular surgery, including LASIK and PRK, within the last 12 months; systemic macrolide within the last month; medication during the study (except: paracetamol and contraceptives).

Sites / Locations

Outcomes

Primary Outcome Measures

Ocular pharmacokinetic in tears

Secondary Outcome Measures

Tolerance

Full Information

NCT ID

NCT00357383

First Posted

July 25, 2006

Last Updated

July 26, 2006

Sponsor

Laboratoires Thea

1. Study Identification

Unique Protocol Identification Number

NCT00357383

Brief Title

Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Official Title

Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2006

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Laboratoires Thea

4. Oversight

5. Study Description

Brief Summary

To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2). To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

Detailed Description

The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

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

Ocular pharmacokinetic in tears

Secondary Outcome Measure Information:

Title

Tolerance

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 subjective ocular symptom; Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4); Registered, or agreed to be registered, in the national register of healthy volunteers Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months; number of corneal stained punctuations >= 5; blepharitis, conjunctivitis, uveitis; contact lenses; topical ocular treatment within the last month; ocular laser within the last 3 months; ocular surgery, including LASIK and PRK, within the last 12 months; systemic macrolide within the last month; medication during the study (except: paracetamol and contraceptives).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier CHASSARD, Dr

Organizational Affiliation

ASTER, Paris, France

Official's Role

Principal Investigator

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