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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Conjunctivitis, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Azithromycin (T1225)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Isabelle COCHEREAU, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU d'Angers, France

Other Identifiers

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LT1225-PIII-11/03

Identifier Type: -

Identifier Source: org_study_id