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

NCT00357383 | Completed Phase 1

• 1 other identifier: LT1225-PI3-07/02(F)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Eye Infections, Bacterial

Outcome Measures

Primary Outcomes (1)

• Ocular pharmacokinetic in tears

Secondary Outcomes (1)

• Tolerance

Interventions

Azithromycin (T1225) DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laboratoires Thea: lead

MeSH Terms

Conditions

Eye Infections, Bacterial

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Didier CHASSARD, Dr

  ASTER, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 27, 2006
• Study Start: October 1, 2002
• Study Completion: October 1, 2002
• Last Updated: July 27, 2006

Record last verified: 2006-07