Purulent Bacterial Conjunctivitis
Conditions
Brief summary
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
Interventions
DRUGT1225
one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
DRUGTobramycin
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
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ one day of life and ≤ 18 years * Purulent bacterial conjunctivitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T1225 T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 | 146 |
| Tobramycin 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 | 136 |
| Total | 282 |
Baseline characteristics
| Characteristic | T1225 | Tobramycin | Total |
|---|---|---|---|
| Age, Continuous | 3.06 years STANDARD_DEVIATION 3.4 | 3.52 years STANDARD_DEVIATION 4.17 | 3.28 years STANDARD_DEVIATION 3.79 |
| Region of Enrollment Algeria | 18 participants | 17 participants | 35 participants |
| Region of Enrollment France | 15 participants | 11 participants | 26 participants |
| Region of Enrollment Germany | 14 participants | 11 participants | 25 participants |
| Region of Enrollment Italy | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Poland | 19 participants | 17 participants | 36 participants |
| Region of Enrollment Portugal | 2 participants | 4 participants | 6 participants |
| Region of Enrollment Romania | 29 participants | 28 participants | 57 participants |
| Region of Enrollment Tunisia | 47 participants | 46 participants | 93 participants |
| Sex: Female, Male Female | 76 Participants | 68 Participants | 144 Participants |
| Sex: Female, Male Male | 70 Participants | 68 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 146 | 0 / 140 |
| serious Total, serious adverse events | 0 / 146 | 0 / 140 |
Outcome results
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).
Time frame: Day 3
Population: The analysis of the primary clinical efficacy variable was primarily performed on the basis of the MFAS. The MFAS consisted of all patients of the FAS with positive Day 0 culture results in an eligible eye.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T1225 | The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 | 48 participants |
| Tobramycin | The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 | 29 participants |