Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00357292
• Collaborator: (none)
• Duration (Months): 1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Eye Infections, Bacterial	Drug: Azithromycin (T1225)	Phase 1

Detailed 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.

Study Design

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

Outcome Measures

Primary Outcome Measures

1. Ocular subjective symptoms []

2. Ocular objective symptoms []

Secondary Outcome Measures

1. Ocular pharmacokinetic. []

2. Ocular and systemic adverse events. []

Eligibility Criteria

Criteria

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

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Laboratoires Thea

Investigators

• Principal Investigator: Khalid TABBARA, Professor, The Eye Center, Riyadh (Saudi Arabia)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00357292
• Other Study ID Numbers: LT1225-PI1-09/01(AS)
• First Posted: Jul 27, 2006
• Last Update Posted: Jul 27, 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 27, 2006