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NCT Number: NCT00356720

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

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

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Key information

Conditions

Trachoma Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Corneal Diseases Eye Diseases Eye Infections Eye Infections, Bacterial Gram-Negative Bacterial Infections Infections

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2004
First posted
Jul 26, 2006
Registry last updated
Jul 26, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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