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

Learn more about:
Related Clinical Trial
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs ) Azithromycin Reduction to Reach Elimination of Trachoma Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis Modified Instrumentation for Surgery to Correct Trichiasis Smartphone App for Taking Images of Conjunctivae Water Uptake for Health in Amhara Pilot A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin Safety and Immunogenicity of a Chlamydia Vaccine CTH522 Fluorometholone as Ancillary Therapy for TT Surgery Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population Impact of Water and Health Education Programs on Trachoma and Ocular C. Trachomatis in Niger Trachoma Elimination Follow-up Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger Azithromycin in Control of Trachoma II Sanitation, Water, and Instruction in Face-washing for Trachoma I/II Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders Trachoma Elimination Study by Focused Antibiotic (TESFA) Kebele Elimination of Trachoma for Ocular Health A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial Testing Insect Repellents Against Musca Sorbens, the Vector of Trachoma Trachoma Amelioration in Northern Amhara (TANA) Tripartite International Research for the Elimination of Trachoma Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania Partnership for Rapid Elimination of Trachoma Nepal Elimination of Trachoma Study Study of Three Alternatives for Mass Treatment in Trachoma Villages of Tanzania

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