Trial Outcomes & Findings for Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children. (NCT NCT01155999)

Last Updated: 2014-10-29

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

286 participants

Primary outcome timeframe

Day 3

Results posted on

2014-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	T1225 T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2	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
Overall Study STARTED	146	140
Overall Study COMPLETED	139	136
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T1225 n=146 Participants T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2	Tobramycin n=136 Participants 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	Total n=282 Participants Total of all reporting groups
Age, Continuous	3.06 years STANDARD_DEVIATION 3.40 • n=5 Participants	3.52 years STANDARD_DEVIATION 4.17 • n=7 Participants	3.28 years STANDARD_DEVIATION 3.79 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	68 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	68 Participants n=7 Participants	138 Participants n=5 Participants
Region of Enrollment France	15 participants n=5 Participants	11 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment Germany	14 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Italy	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Poland	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants
Region of Enrollment Portugal	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Romania	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants
Region of Enrollment Algeria	18 participants n=5 Participants	17 participants n=7 Participants	35 participants n=5 Participants
Region of Enrollment Tunisia	47 participants n=5 Participants	46 participants n=7 Participants	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	T1225 n=102 Participants T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2	Tobramycin n=101 Participants 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
The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3	48 participants	29 participants

Adverse Events

T1225

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tobramycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pascale Pouliquen (Medical director)

Laboratoires Thea

Phone: 0473963614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
Publication restrictions are in place

Restriction type: OTHER