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

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT00356720
Collaborator
(none)
4
Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date :
Jan 1, 2004
Study Completion Date :
May 1, 2004

Outcome Measures

Primary Outcome Measures

  1. 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 []

  2. at the end of the study []

Secondary Outcome Measures

  1. Cure at Days 30 and 60, []

  2. cure in both eyes, []

  3. trachoma grades at each visit; []

  4. microbiological cure; []

  5. Ocular signs (bulbar conjunctival hyperaemia, discharge; lachrymation; []

  6. Global efficacy assessment by investigator. []

  7. Tolerance []

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Laboratoires Thea

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00356720
Other Study ID Numbers:
  • LT1225-PIII-10/03
First Posted:
Jul 26, 2006
Last Update Posted:
Jul 26, 2006
Last Verified:
Jul 1, 2006
Additional relevant MeSH terms:
Trachoma
Azithromycin

Study Results

No Results Posted as of Jul 26, 2006