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

This study has been completed.

First Received: July 25, 2006 Last Updated: July 26, 2006 History of Changes

Sponsored by:	Laboratoires Thea
Information provided by:	Laboratoires Thea
ClinicalTrials.gov Identifier:	NCT00357292

Purpose

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	Intervention	Phase
Eye Infections, Bacterial	Drug: Azithromycin (T1225)	Phase I

MedlinePlus related topics: Eye Infections

Drug Information available for: Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:

Ocular subjective symptoms
Ocular objective symptoms

Secondary Outcome Measures:

Ocular pharmacokinetic.
Ocular and systemic adverse events.

Study Start Date:	March 2002
Estimated Study Completion Date:	April 2002

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357292

Sponsors and Collaborators

Laboratoires Thea

Investigators

Principal Investigator:

Khalid TABBARA, Professor

The Eye Center, Riyadh (Saudi Arabia)

More Information

No publications provided

Study ID Numbers:	LT1225-PI1-09/01(AS)
Study First Received:	July 25, 2006
Last Updated:	July 26, 2006
ClinicalTrials.gov Identifier:	NCT00357292 History of Changes
Health Authority:	United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Eye Infections, Bacterial
Azithromycin

Eye Diseases
Eye Infections
Healthy

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Eye Infections, Bacterial
Therapeutic Uses

Azithromycin
Eye Diseases
Eye Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009