Trial Outcomes & Findings for Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer (NCT NCT01794312)

NCT ID: NCT01794312

Last Updated: 2019-10-23

Results Overview

Reduction in neurotrophic ulcer/keratitis area of 50% or more

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 152 participants
• Primary outcome timeframe: Day 28
• Results posted on: 2019-10-23

Participant Flow

Participant milestones

Measure	T4020 One drop every 2 days	Vehicle One drop every 2 days
Overall Study STARTED	74	78
Overall Study COMPLETED	68	67
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	T4020 n=74 Participants One drop every 2 days	Vehicle n=78 Participants One drop every 2 days	Total n=152 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=74 Participants	1 Participants n=78 Participants	1 Participants n=152 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=74 Participants	32 Participants n=78 Participants	69 Participants n=152 Participants
Age, Categorical >=65 years	37 Participants n=74 Participants	45 Participants n=78 Participants	82 Participants n=152 Participants
Age, Continuous	62.2 years STANDARD_DEVIATION 17 • n=74 Participants	65.2 years STANDARD_DEVIATION 17.8 • n=78 Participants	63.8 years STANDARD_DEVIATION 17.4 • n=152 Participants
Sex: Female, Male Female	40 Participants n=74 Participants	42 Participants n=78 Participants	82 Participants n=152 Participants
Sex: Female, Male Male	34 Participants n=74 Participants	36 Participants n=78 Participants	70 Participants n=152 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	16 participants n=74 Participants	20 participants n=78 Participants	36 participants n=152 Participants
Region of Enrollment Poland	12 participants n=74 Participants	14 participants n=78 Participants	26 participants n=152 Participants
Region of Enrollment Turkey	8 participants n=74 Participants	7 participants n=78 Participants	15 participants n=152 Participants
Region of Enrollment Belgium	6 participants n=74 Participants	8 participants n=78 Participants	14 participants n=152 Participants
Region of Enrollment Italy	7 participants n=74 Participants	6 participants n=78 Participants	13 participants n=152 Participants
Region of Enrollment Spain	7 participants n=74 Participants	5 participants n=78 Participants	12 participants n=152 Participants
Region of Enrollment Greece	6 participants n=74 Participants	6 participants n=78 Participants	12 participants n=152 Participants
Region of Enrollment Switzerland	4 participants n=74 Participants	4 participants n=78 Participants	8 participants n=152 Participants
Region of Enrollment Netherlands	4 participants n=74 Participants	4 participants n=78 Participants	8 participants n=152 Participants
Region of Enrollment Sweden	2 participants n=74 Participants	1 participants n=78 Participants	3 participants n=152 Participants
Region of Enrollment United Kingdom	1 participants n=74 Participants	2 participants n=78 Participants	3 participants n=152 Participants
Region of Enrollment Austria	0 participants n=74 Participants	1 participants n=78 Participants	1 participants n=152 Participants
Region of Enrollment Portugal	1 participants n=74 Participants	0 participants n=78 Participants	1 participants n=152 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Modified Intent to treat (m-ITT): All randomised patients received at least 1 IMP dose, with at least 1 baseline and 1 post-baseline efficacy assessment. For the primary outcome measure, 4 patients (2 in the T4020 and Vehicle groups) had no data for the reduction from baseline of corneal ulcer/keratitis area and were not included in this analysis

Reduction in neurotrophic ulcer/keratitis area of 50% or more

Outcome measures

Measure	T4020 n=72 Participants One drop every 2 days	Vehicle n=76 Participants One drop every 2 days
Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28	37 Participants	44 Participants

SECONDARY outcome

Timeframe: From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days

Population: Safety Set

With at least one TEAE

Outcome measures

Measure	T4020 n=74 Participants One drop every 2 days	Vehicle n=78 Participants One drop every 2 days
Number of Participants With at Least One Treatment-emergent Adverse Event	25 Participants	27 Participants

SECONDARY outcome

Timeframe: Baseline and Day 28

Population: Safety set

Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye

Outcome measures

Measure	T4020 n=74 Participants One drop every 2 days	Vehicle n=78 Participants One drop every 2 days
Best Corrected Visual Acuity	-0.055 LogMAR Standard Deviation 0.362	-0.035 LogMAR Standard Deviation 0.590

Adverse Events

T4020

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Vehicle

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	T4020 n=74 participants at risk One drop 4 times per week	Vehicle n=78 participants at risk One drop 4 times per week
Eye disorders Ulcerative keratitis	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Infections and infestations Herpes Simplex ophthalmic	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Keratitis	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Corneal neovascularisation	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Infections and infestations Corneal infection	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Uveitis	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Corneal perforation	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Infections and infestations Keratitis bacterial	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Surgical and medical procedures Tooth extraction	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days

Other adverse events

Measure	T4020 n=74 participants at risk One drop 4 times per week	Vehicle n=78 participants at risk One drop 4 times per week
Eye disorders Ulcerative keratitis	4.1% 3/74 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	5.1% 4/78 • Number of events 4 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Infections and infestations Hypopyon, Keratitis bacterial, Keratitis herpetic, Corneal infection, Dacryocanaliculitis, Dacryocys	4.1% 3/74 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	11.5% 9/78 • Number of events 9 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
General disorders Instillation site reaction	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Investigations Vital dye staining cornea present	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Vascular disorders Hyperaemia	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Conjuncticitis allergic, diplopia	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Infections and infestations Device related infection, Gastroenteritis, Oral herpes, Urinary tract infection	5.4% 4/74 • Number of events 4 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Nervous system disorders Headache	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	3.8% 3/78 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Injury, poisoning and procedural complications Femoral neck fracture, Road traffic accident	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
General disorders Influenza like illness	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Immune system disorders Seasonal allergy	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Reproductive system and breast disorders Begnin prostatic hyperplasia	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Skin and subcutaneous tissue disorders Nail bed bleeding	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Surgical and medical procedures Tooth extraction	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Keratitis	4.1% 3/74 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Eye pain	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	3.8% 3/78 • Number of events 3 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Eye irritation	2.7% 2/74 • Number of events 2 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Abnormal sensation in eye	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Acanthamoeba keratitis	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Conjunctival hemorrhage	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Conjunctivitis	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Conjunctivitis allergic	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Corneal epithelium defect	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Corneal erosion	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Corneal neovascularisation	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Corneal perforation	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Diplopia	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Dry eye	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Foreign body sensation in eyes	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Iridocyclitis	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Neurotrophic keratopathy	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Ocular hyperaemia	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Punctate keratitis	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Uveitis	0.00% 0/74 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	1.3% 1/78 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Vision blurred	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Visual acuity reduced	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Eye disorders Vitreous floaters	1.4% 1/74 • Number of events 1 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days	0.00% 0/78 • From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days

Additional Information

Clinical Development Director

Laboratoires Théa

Phone: +33(0)473981414

Email: Corentin.LECAMUS@theapharma.com

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