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

Thea Pharma

Status and phase: Completed; Phase 3

Conditions: Purulent Bacterial Conjunctivitis

Treatments: Drug: T1225; Drug: Tobramycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01155999

2008-003567-39 (EudraCT Number)

LT1225-PIIIB-02/08

Details and patient eligibility

About

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

Enrollment: 286 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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286 participants in 2 patient groups

T1225

Experimental group

Treatment:

Drug: T1225

Tobramycin

Active Comparator group

Treatment:

Drug: Tobramycin