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

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00356850
• Collaborator: (none)
• Duration (Months): 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Infections, Bacterial	Drug: Azithromycin	Phase 1

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2002
• Study Completion Date: Jun 1, 2002

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve from 0 to 24 hours (AUC0-24h) []

2. Elimination half-life (t1/2) []

3. Maximum Concentration (Cmax) []

4. Concentration 24 hours after instillation (C24h) []

Secondary Outcome Measures

1. Tolerance []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Laboratoires Thea

Investigators

• Principal Investigator: Claude DUBRAY, Professor, Centre de Pharmacologie Clinique - Clermont-Ferrand (France)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00356850
• Other Study ID Numbers: LT1225-PI2-03/02(F)
• First Posted: Jul 26, 2006
• Last Update Posted: Jul 26, 2006
• Last Verified: Jul 1, 2006

• Additional relevant MeSH terms: Bacterial Infections; Eye Infections; Eye Infections, Bacterial; Azithromycin

Study Results

No Results Posted as of Jul 26, 2006