Trial Outcomes & Findings for Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome (NCT NCT01568593)

Results Overview

Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

93 participants

Primary outcome timeframe

Baseline and 35 days

Results posted on

2016-04-04

Participant milestones
Measure	T2750 T2750: 1 drop in each eye 3 to 6 times daily during 84 days	Vismed Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
Overall Study STARTED	48	45
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal
Measure	T2750 T2750: 1 drop in each eye 3 to 6 times daily during 84 days	Vismed Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
Overall Study Lack of Efficacy	4	1
Overall Study Adverse Event	3	2

Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Baseline characteristics by cohort
Measure	T2750 n=48 Participants T2750: 1 drop in each eye 3 to 6 times daily during 84 days	Vismed n=45 Participants Vismed: 1 drop in each eye 3 to 6 times daily during 84 days	Total n=93 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 11.2 • n=93 Participants	63.6 years STANDARD_DEVIATION 10 • n=4 Participants	62.8 years STANDARD_DEVIATION 10.6 • n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	38 Participants n=4 Participants	78 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Time from the dry eye diagnosis	7.18 years STANDARD_DEVIATION 6.98 • n=93 Participants	6.2 years STANDARD_DEVIATION 5.41 • n=4 Participants	6.71 years STANDARD_DEVIATION 6.25 • n=27 Participants

Timeframe: Baseline and 35 days

Population: Per Protocol Population

Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)

Outcome measures
Measure	T2750 n=42 Participants T2750: 1 drop in each eye 3 to 6 times daily during 84 days	Vismed n=40 Participants Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
Global Ocular Staining (With Oxford Scale - Ranges :0-15)	-1.8 scores on a scale Standard Deviation 2.2	-2 scores on a scale Standard Deviation 1.4

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	T2750 n=48 participants at risk T2750: 1 drop in each eye 3 to 6 times daily during 84 days	Vismed n=45 participants at risk Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
Psychiatric disorders Depression	2.1% 1/48	0.00% 0/45

Adverse event data not reported

Laboratoires Thea

Phone: 0473981436

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 from without prior written agreement of THEA
Publication restrictions are in place

Restriction type: OTHER