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

Purulent Bacterial Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155999
• Other study ID #: LT1225-PIIIB-02/08
• Secondary ID: 2008-003567-39
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2010
• Last updated: October 24, 2014
• Start date: December 2008
• Est. completion date: February 2011

Study information

• Verified date: September 2011
• 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)Germany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicinal Products and Health ProductsPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyTunisia: Ministry of Public HealthAlgeria: Ministry of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age = one day of life and = 18 years

• Purulent bacterial conjunctivitis

Study Design

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

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Bacterial
• Purulent Bacterial Conjunctivitis

Intervention

Drug:
• T1225
one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
• Tobramycin
1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on 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).	Day 3	No