Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.

Phase 3

Completed

• Conditions: Purulent Bacterial Conjunctivitis
• Interventions: Drug: T1225; Drug: Tobramycin

• Registration Number: NCT01155999
• Lead Sponsor: Laboratoires Thea

Brief Summary

Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-09
• Results First Submitted: 2014-10-24
• Results First Submitted QC: 2014-10-24
• Last Update Submitted: 2014-10-24
• Results First Posted: 2014-10-29
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Age ≥ one day of life and ≤ 18 years
• Purulent bacterial conjunctivitis

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T1225	T1225	-
Tobramycin	Tobramycin	-

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3	Day 3	Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).