Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis

Conjunctivitis, Bacterial Clinical Trial

Official title:

Clinical Efficacy and Safety of T1225 1.5% Eye Drops (3-Day Treatment) Versus Tobramycin 0.3 % Eye Drops (7-Day Treatment) in the Treatment of Purulent Bacterial Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357773
• Other study ID #: LT1225-PIII-11/03
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2006
• Last updated: July 26, 2006
• Start date: May 2004
• Est. completion date: June 2005

Study information

• Verified date: July 2006
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety

Description:

The aim of the present study was to compare the efficacy and safety of T1225 1.5% eye drops administered BID for 3 days in comparison to reference antibiotic eye drops, tobramycin, for the treatment of purulent bacterial conjunctivitis. The study was conducted as a Phase III, multicentre, international, investigator-masked, randomised, parallel-group, non-inferiority study in newborns, children, and adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or female >= 1 day old (newborn, infant, child, adult);

• written informed consent by patient or legally acceptable representative;

• purulent bacterial conjunctivitis (unilateral or bilateral) defined as bulbar conjunctival injection (mild, moderate, or severe) AND conjunctival purulent discharge (mild, moderate or severe).

Exclusion Criteria:

• Bacterial conjunctivitis diagnosed >= 7 days ago;

• bacterial infection due to trauma or foreign body;

• dacryocystitis;

• corneal ulceration or keratitis;

• viral ocular infection; closed angle glaucoma;

• acute allergy conjunctivitis;

• clinically significant ocular abnormality;

• organic amblyopia, monophthalmia;

• corrected visual acuity below 20/100;

• contact lens wearer;

• newborn (i.e. 0-2 months old) not born at term (< 37 weeks of amenorrhea);

• ocular surgery, laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), or photo-refractive keratectomy (PRK) in last 12 months;

• ocular laser treatment in last 3 months;

• systemic macrolide antibiotics in last month;

• systemic steroids in last 2 weeks or during the study;

• topical ocular macrolide antibiotics and/or topical ocular steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) in last week;

• topical (ocular, nasal, bronchial etc.) treatments and/or systemic NSAIDs in last day;

• immunosuppressives and/or any systemic antibiotic on D0.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• Azithromycin (T1225)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure in the worse eye on Test of Cure (TOC) visit at Day 9, defined as a score 0 for bulbar conjunctival injection and a score 0 for conjunctival purulent discharge (each graded on 4-point scales)
Secondary	Clinical cure at Day 3
Secondary	Microbiological cure at Day 3 and Day 9
Secondary	Global efficacy.
Secondary	Tolerance