Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
2 other identifiers
interventional
286
1 country
1
Brief Summary
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 30, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
October 29, 2014
CompletedOctober 29, 2014
September 1, 2011
2.2 years
June 30, 2010
October 24, 2014
October 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
T1225
EXPERIMENTALTobramycin
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- Age ≥ one day of life and ≤ 18 years
- Purulent bacterial conjunctivitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Clermont-Ferrand, 63000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pascale Pouliquen (Medical director)
- Organization
- Laboratoires Thea
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2010
First Posted
July 2, 2010
Study Start
December 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
October 29, 2014
Results First Posted
October 29, 2014
Record last verified: 2011-09