Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

Eye Infections, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356850
• Other study ID #: LT1225-PI2-03/02(F)
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2006
• Last updated: July 25, 2006
• Start date: May 2002
• Est. completion date: June 2002

Study information

• Verified date: July 2006
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Eye Infections
• Eye Infections, Bacterial

Intervention

Drug:
• Azithromycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve from 0 to 24 hours (AUC0-24h)
Primary	Elimination half-life (t1/2)
Primary	Maximum Concentration (Cmax)
Primary	Concentration 24 hours after instillation (C24h)
Secondary	Tolerance