Back to resultsEfficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma
Primary Purpose
Trachoma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Trachoma
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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00356720
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratoires Thea
4. Oversight
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Primary Outcome Measure Information:
Title
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
Title
at the end of the study
Secondary Outcome Measure Information:
Title
Cure at Days 30 and 60,
Title
cure in both eyes,
Title
trachoma grades at each visit;
Title
microbiological cure;
Title
Ocular signs (bulbar conjunctival hyperaemia, discharge; lachrymation;
Title
Global efficacy assessment by investigator.
Title
Tolerance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle COCHEREAU, Professor
Organizational Affiliation
CHU d'Angers, France
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma
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