Trial Outcomes & Findings for Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome (NCT NCT02023268)

NCT ID: NCT02023268

Last Updated: 2017-08-24

Results Overview

Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 105 participants
• Primary outcome timeframe: Baseline and Day 35
• Results posted on: 2017-08-24

Participant Flow

Participant milestones

Measure	T2762 T2762: 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	52	53
Overall Study COMPLETED	52	49
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Measure	T2762 T2762: 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	0	1
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome

Baseline characteristics by cohort

Measure	T2762 n=52 Participants T2762: 1 drop in each eye 3 to 6 times daily during 84 days	Vismed® n=53 Participants Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 12.2 • n=5 Participants	58.5 years STANDARD_DEVIATION 13.4 • n=7 Participants	59.2 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	45 Participants n=7 Participants	86 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment France	31 participants n=5 Participants	31 participants n=7 Participants	62 participants n=5 Participants
Region of Enrollment Tunisia	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 35

Population: 14 patients with major protocol deviations were excluded of the analysed population.

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

Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).

Outcome measures

Measure	T2762 n=46 Participants T2762: 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
Global Ocular Staining (With Oxford Scale - Ranges : 0-15)	-2.5 score on a scale Standard Deviation 2.0	-2.7 score on a scale Standard Deviation 1.7

Adverse Events

T2762

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vismed®

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

Dr Pascale Pouliquen

Laboratoires Théa

Phone: 04 73 98 14 36

Email: p.pouliquen@laboratoires-thea.fr

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

Restriction type: OTHER