Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 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: NCT00357292
• Other study ID #: LT1225-PI1-09/01(AS)
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2006
• Last updated: July 26, 2006
• Start date: March 2002
• Est. completion date: April 2002

Study information

• Verified date: July 2006
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation

Description:

The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after 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: April 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;

• Blepharitis;

• Conjunctival hyperaemia (score >= 2 +);

• Watering (score >= 2);

• Contact lenses;

• Ocular surgery, including LASIK and PRK, within the last 12 months;

• Topical ocular treatment within the last month;

• Systemic antibiotics within the last 7 days;

• Any 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular subjective symptoms
Primary	Ocular objective symptoms
Secondary	Ocular pharmacokinetic.
Secondary	Ocular and systemic adverse events.