Trial Outcomes & Findings for Efficacy of T2259 in DED (NCT NCT03874429)

NCT ID: NCT03874429

Last Updated: 2023-11-01

Results Overview

Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: Baseline and Day 35
• Results posted on: 2023-11-01

Participant Flow

Participant milestones

Measure	T2259 1 drop in each eye 2 to 4 times daily 3 months treatment period lasted from randomisation visit (Day 1 ; Visit #2) to the final visit (Day 84 (7 days) ; Visit #5)	Vismed Multi 1 drop in each eye 2 to 4 times daily 3 months treatment period lasted from randomisation visit (Day 1 ; Visit #2) to the final visit (Day 84 (7 days) ; Visit #5)
Overall Study STARTED	50	51
Overall Study COMPLETED	44	46
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	T2259 1 drop in each eye 2 to 4 times daily 3 months treatment period lasted from randomisation visit (Day 1 ; Visit #2) to the final visit (Day 84 (7 days) ; Visit #5)	Vismed Multi 1 drop in each eye 2 to 4 times daily 3 months treatment period lasted from randomisation visit (Day 1 ; Visit #2) to the final visit (Day 84 (7 days) ; Visit #5)
Overall Study Adverse Event	2	2
Overall Study Lack of Efficacy	0	1
Overall Study Covid-19 pandemic	4	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	T2259 n=49 Participants 1 drop in each eye 2 to 4 times daily T2259	Vismed Multi n=49 Participants 1 drop in each eye 2 to 4 times daily Vismed multi	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=49 Participants	0 Participants n=49 Participants	0 Participants n=98 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=49 Participants	41 Participants n=49 Participants	65 Participants n=98 Participants
Age, Categorical >=65 years	25 Participants n=49 Participants	8 Participants n=49 Participants	33 Participants n=98 Participants
Age, Continuous age	62.4 years STANDARD_DEVIATION 13.7 • n=49 Participants	55.5 years STANDARD_DEVIATION 13.1 • n=49 Participants	59 years STANDARD_DEVIATION 13.8 • n=98 Participants
Sex: Female, Male Female	43 Participants n=49 Participants	44 Participants n=49 Participants	87 Participants n=98 Participants
Sex: Female, Male Male	6 Participants n=49 Participants	5 Participants n=49 Participants	11 Participants n=98 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	11 participants n=49 Participants	8 participants n=49 Participants	19 participants n=98 Participants
Region of Enrollment Spain	12 participants n=49 Participants	10 participants n=49 Participants	22 participants n=98 Participants
Region of Enrollment Poland	4 participants n=49 Participants	6 participants n=49 Participants	10 participants n=98 Participants
Region of Enrollment Slovakia	22 participants n=49 Participants	25 participants n=49 Participants	47 participants n=98 Participants

PRIMARY outcome

Timeframe: Baseline and Day 35

Population: PP population

Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)

Outcome measures

Measure	T2259 n=42 Participants 1 drop in each eye 2 to 4 times daily	Vismed Multi n=42 Participants 1 drop in each eye 2 to 4 times daily
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)	-1.45 score on a scale Standard Deviation 1.88	-1.79 score on a scale Standard Deviation 1.68

Adverse Events

T2259

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Vismed Multi

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	T2259 n=50 participants at risk 1 drop in each eye 2 to 4 times daily	Vismed Multi n=51 participants at risk 1 drop in each eye 2 to 4 times daily
Psychiatric disorders Depression	0.00% 0/50 • 15 weeks from D-10 to D84 (±7 days)	2.0% 1/51 • Number of events 1 • 15 weeks from D-10 to D84 (±7 days)

Other adverse events

Measure	T2259 n=50 participants at risk 1 drop in each eye 2 to 4 times daily	Vismed Multi n=51 participants at risk 1 drop in each eye 2 to 4 times daily
Nervous system disorders Headache	8.0% 4/50 • Number of events 4 • 15 weeks from D-10 to D84 (±7 days)	0.00% 0/51 • 15 weeks from D-10 to D84 (±7 days)

Additional Information

Corentin Le Camus

Laboratoires Thea

Phone: 0680382020

Email: corentin.lecamus@theapharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place