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

Eye Infections, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357539
• Other study ID #: LT1225-PI1-09/01(F)
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2006
• Last updated: July 26, 2006
• Start date: February 2002
• Est. completion date: March 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 compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

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.

Recruitment information / eligibility

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

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety 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 (T1225)

Locations

Country	Name	City	State
France	Unité de Pharmacologie Clinique	Clermont Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective ocular symptoms
Primary	Objective ocular symptoms
Secondary	Systemic adverse events
Secondary	Ocular adverse events
Secondary	Ocular pharmacokinetic