Phase 3
N=286
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
Purulent Bacterial Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01155999 ↗Enrolled (actual)
286
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 — 48; 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- T1225 (Drug); Tobramycin (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Laboratoires Thea
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 |
48; 29 | — |
Summary
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
Eligibility Criteria
Inclusion Criteria
- Age ≥ one day of life and ≤ 18 years
- Purulent bacterial conjunctivitis
Data sourced from ClinicalTrials.gov (NCT01155999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.