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

Eye Infections, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357383
• Other study ID #: LT1225-PI3-07/02(F)
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2006
• Last updated: July 26, 2006
• Start date: October 2002
• Est. completion date: October 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 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 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).

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 (T1225)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular pharmacokinetic in tears
Secondary	Tolerance