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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trachoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Azithromycin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Isabelle COCHEREAU, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU d'Angers, France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LT1225-PIII-10/03

Identifier Type: -

Identifier Source: org_study_id