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

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Brief Title

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

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

Brief Summary

      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

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Cure at Days 30 and 60,

Condition

Trachoma

Intervention

Azithromycin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Start Date

January 2004

Completion Date

May 2004

Eligibility 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

Gender

All

Ages

1 Year - 10 Years

Accepts Healthy Volunteers

No

Contacts

Isabelle COCHEREAU, Professor, ,

Administrative Informations

NCT ID

NCT00356720

Organization ID

LT1225-PIII-10/03

Study Sponsor

Laboratoires Thea

Study Sponsor

Isabelle COCHEREAU, Professor, Principal Investigator, CHU d'Angers, France

Verification Date

July 2006