A Phase 3 interventional study of T1225 and Tobramycin in Purulent Bacterial Conjunctivitis, sponsored by Laboratoires Thea. Completed at 1 site in France. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2014-10-29.
Sponsored by Laboratoires Thea · Phase 3, Interventional, and Treatment
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 286 is close to the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Laboratoires Thea is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Drug: T1225
Drug: Tobramycin
one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
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
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
| Milestone | T1225 | Tobramycin |
|---|---|---|
| Started | 146 | 140 |
| Completed | 139 | 136 |
| Not completed | 7 | 4 |
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).
| participants | T1225 | Tobramycin |
|---|---|---|
| The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 | 48 | 29 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| T1225 | — | 0/146 (0%) | 0/146 (0%) |
| Tobramycin | — | 0/140 (0%) | 0/140 (0%) |
| Age, Continuous(years) | T1225 | Tobramycin | Total |
|---|---|---|---|
| Mean | 3.06 ± 3.40 | 3.52 ± 4.17 | 3.28 ± 3.79 |
| Sex: Female, Male(Participants) | T1225 | Tobramycin | Total |
|---|---|---|---|
| Female | 76 | 68 | 144 |
| Male | 70 | 68 | 138 |
| Region of Enrollment(participants) | T1225 | Tobramycin | Total |
|---|---|---|---|
| France | 15 | 11 | 26 |
| Germany | 14 | 11 | 25 |
| Italy | 2 | 2 | 4 |
| Poland | 19 | 17 | 36 |
| Portugal | 2 | 4 | 6 |
| Romania | 29 | 28 | 57 |
| Algeria | 18 | 17 | 35 |
| Tunisia | 47 | 46 | 93 |
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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