Trial Outcomes & Findings for Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking (NCT NCT02979054)

NCT ID: NCT02979054

Last Updated: 2019-10-22

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

157 participants

Primary outcome timeframe

Day 3

Results posted on

2019-10-22

Participant Flow

157 screened patients disposed as: 135 patients treated and randomised, 20 patients not included (reasons: screen failures: 14, protocol violation: 1, consent withdrawal: 4 and other reasons: 1) and 2 patients treated but not randomised.

Participant milestones

Participant milestones
Measure	T4020 1 drop every other day during 5 days T4020	Saline Solution 1 drop every other day during 5 days Placebo
Overall Study STARTED	71	64
Overall Study COMPLETED	71	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T4020 n=71 Participants 1 drop every other day during 5 days T4020	Saline Solution n=64 Participants 1 drop every other day during 5 days Placebo	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	5 Participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	8 Participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Age, Categorical Between 18 and 65 years	68 Participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	59 Participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	127 Participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Age, Categorical >=65 years	0 Participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	0 Participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	0 Participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Age, Continuous	27.5 years STANDARD_DEVIATION 7.9 • n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	28.9 years STANDARD_DEVIATION 10.2 • n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	28.1 years STANDARD_DEVIATION 9.1 • n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Sex: Female, Male Female	21 Participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	20 Participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	41 Participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Sex: Female, Male Male	50 Participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	44 Participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	94 Participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	19 participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	18 participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	37 participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Region of Enrollment France	21 participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	17 participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	38 participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Region of Enrollment Bulgaria	15 participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	14 participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	29 participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
Region of Enrollment Spain	16 participants n=71 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	15 participants n=64 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.	31 participants n=135 Participants • 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.

PRIMARY outcome

Timeframe: Day 3

Population: mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.

Outcome measures

Outcome measures
Measure	T4020 n=71 Participants 1 drop every other day during 5 days T4020	Saline Solution n=64 Participants 1 drop every other day during 5 days Placebo
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3	20 Participants	25 Participants

PRIMARY outcome

Timeframe: Day 4

Outcome measures

Outcome measures
Measure	T4020 n=71 Participants 1 drop every other day during 5 days T4020	Saline Solution n=64 Participants 1 drop every other day during 5 days Placebo
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4	47 Participants	47 Participants

SECONDARY outcome

Timeframe: Baseline and Day 5

Outcome measures

Outcome measures
Measure	T4020 n=71 Participants 1 drop every other day during 5 days T4020	Saline Solution n=64 Participants 1 drop every other day during 5 days Placebo
Corneal Epithelial Defect Size Assessment	1.0 mm^2 Standard Deviation 4.6	1.9 mm^2 Standard Deviation 6.9

SECONDARY outcome

Timeframe: Through study completion, an average of 1 month

Population: Safety set (137 treated participants)

Outcome measures

Outcome measures
Measure	T4020 n=73 Participants 1 drop every other day during 5 days T4020	Saline Solution n=64 Participants 1 drop every other day during 5 days Placebo
Number of Participants With Treatment-emergent Adverse Events	12 Participants	8 Participants

Adverse Events

T4020

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Saline Solution

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Development Director

Laboratoires Théa

Phone: +33(0)473981414

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

Measure	T4020 n=73 participants at risk 1 drop every other day during 5 days T4020	Saline Solution n=64 participants at risk 1 drop every other day during 5 days Placebo
Eye disorders Conjunctival hyperaemia	4.1% 3/73 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	1.6% 1/64 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
General disorders Malabsorption from application site	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Infections and infestations Conjunctivitis	0.00% 0/73 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	1.6% 1/64 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Gastrointestinal disorders Nausea	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Infections and infestations Nasopharyngitis	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Injury, poisoning and procedural complications Procedural nausea	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Nervous system disorders Headache	4.1% 3/73 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Contact lens intolerance	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Corneal disorder	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Corneal infiltrates	0.00% 0/73 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	1.6% 1/64 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Corneal oedema	4.1% 3/73 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	3.1% 2/64 • Number of events 2 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Corneal opacity	2.7% 2/73 • Number of events 2 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Eye pain	4.1% 3/73 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	1.6% 1/64 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Eyelid oedema	2.7% 2/73 • Number of events 2 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Keratitis	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Ocular discomfort	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Ocular hyperaemia	0.00% 0/73 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	3.1% 2/64 • Number of events 2 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Punctate keratitis	2.7% 2/73 • Number of events 2 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	1.6% 1/64 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Eye disorders Vision blurred	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.
Infections and infestations Eye infection	1.4% 1/73 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.	0.00% 0/64 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.