Back to resultsOcular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers
Primary Purpose
Eye Infections, Bacterial
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Eye Infections, Bacterial
Eligibility Criteria
Inclusion Criteria: Male/female aged from 18 to 45 years; Written informed consent; Healthy volunteers without any subjective ocular symptom; Corrected visual acuity >= 6/10; Registered in the national register of healthy volunteers Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; Conjunctival hyperaemia (score >= 2); Folliculo-papillary conjunctivitis (score >= 2); Topical ocular treatment within the last month; Ocular surgery, including LASIK and PRK, within the last 12 months; Other ocular laser within the last 3 months; Zithromax® and Azadose® within the last 3 months; Medication during the study (except: paracetamol, contraceptives
Sites / Locations
Outcomes
Primary Outcome Measures
Area Under the Curve from 0 to 24 hours (AUC0-24h)
Elimination half-life (t1/2)
Maximum Concentration (Cmax)
Concentration 24 hours after instillation (C24h)
Secondary Outcome Measures
Tolerance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00356850
Brief Title
Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers
Official Title
Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratoires Thea
4. Oversight
5. Study Description
Brief Summary
To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.
Detailed Description
The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single 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
Primary Outcome Measure Information:
Title
Area Under the Curve from 0 to 24 hours (AUC0-24h)
Title
Elimination half-life (t1/2)
Title
Maximum Concentration (Cmax)
Title
Concentration 24 hours after instillation (C24h)
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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male/female aged from 18 to 45 years;
Written informed consent;
Healthy volunteers without any subjective ocular symptom;
Corrected visual acuity >= 6/10;
Registered in the national register of healthy volunteers
Exclusion Criteria:
Ocular trauma, infection or inflammation within the last 3 months;
Conjunctival hyperaemia (score >= 2);
Folliculo-papillary conjunctivitis (score >= 2);
Topical ocular treatment within the last month;
Ocular surgery, including LASIK and PRK, within the last 12 months;
Other ocular laser within the last 3 months;
Zithromax® and Azadose® within the last 3 months;
Medication during the study (except: paracetamol, contraceptives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude DUBRAY, Professor
Organizational Affiliation
Centre de Pharmacologie Clinique - Clermont-Ferrand (France)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers
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