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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356720
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : July 26, 2006
Information provided by:
Laboratoires Thea

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
Trachoma Drug: Azithromycin 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 Type : Interventional  (Clinical Trial)
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 : January 2004
Estimated Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

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

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00356720

Sponsors and Collaborators
Laboratoires Thea
Principal Investigator: Isabelle COCHEREAU, Professor CHU d'Angers, France Identifier: NCT00356720     History of Changes
Other Study ID Numbers: LT1225-PIII-10/03
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: July 26, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions