Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma - Full Text View

Sponsor:	Laboratoires Thea
Information provided by:	Laboratoires Thea
ClinicalTrials.gov Identifier:	NCT00356720

Purpose

To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops, in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure at Day 60 in Per Protocol Set), microbiological evaluation was secondary

Condition	Intervention	Phase
Trachoma	Drug: Azithromycin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Clinical Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% (Instilled Twice Daily for 2 or 3 Days) Versus Oral Azithromycin in Treatment of Trachoma

Resource links provided by NLM:

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:

Cure at end of study, i.e. TF0 grade on simplified WHO trachoma grading system < 5 follicles ≥ 0.5 mm diameter in upper tarsal conjunctiva) in the worse eye
at the end of the study

Secondary Outcome Measures:

Cure at Days 30 and 60,
cure in both eyes,
trachoma grades at each visit;
microbiological cure;
Ocular signs (bulbar conjunctival hyperaemia, discharge; lachrymation;
Global efficacy assessment by investigator.
Tolerance

Study Start Date:	January 2004
Estimated Study Completion Date:	May 2004

Detailed Description:

The aim of the present study was to compare the efficacy of the dosing regimen which was demonstrated in pharmacokinetic studies to be the best candidate for trachoma treatment (T1225 1.5% eye drops BID for 3 days) with a shorter duration of treatment (T1225 1.5% eye drops BID for 2 days) and with a single oral administration of AZM (20 mg/kg) in patients suffering from active trachoma. The study was to be performed in approximately 600 children (aged 1 to 10 years) from Guinea Conakry and Pakistan.

Eligibility

Ages Eligible for Study:	1 Year to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female aged 1-10 years;
written informed consent by legally acceptable representative;
TF+ TI0 (trachomatous inflammation – follicular) or TF+TI+ (trachomatous inflammation – follicular and intense) on simplified World Health Organisation (WHO) grading system

Exclusion Criteria:

Trichiasis or corneal opacity;
palpebral deformation;
clinically significant ocular abnormality;
ocular infection;
organic amblyopia;
hypersensitivity to treatments' components;
immunosuppressive conditions;
systemic AZM or steroids;
topical ophthalmic antibiotics within 3 months;
other systemic antibiotics within 1 month;
topical (ocular, nasal, bronchial etc.) treatments within 1 week;
systemic non-steroidal anti-inflammatory drugs on day before Day 0

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356720

Sponsors and Collaborators

Laboratoires Thea

Investigators

Principal Investigator:

Isabelle COCHEREAU, Professor

CHU d'Angers, France

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00356720 History of Changes
Other Study ID Numbers:	LT1225-PIII-10/03
Study First Received:	July 25, 2006
Last Updated:	July 25, 2006
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection

Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012