Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT01794312
Collaborator
(none)
152
Enrollment
1
Location
2
Arms
58.5
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: T4020
  • Device: Vehicle
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Actual Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Dec 19, 2017
Actual Study Completion Date :
Dec 19, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: T4020

One drop every 2 days

Device: T4020

Placebo Comparator: Vehicle

One drop every 2 days

Device: Vehicle

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 [Day 28]

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

Secondary Outcome Measures

  1. Number of Participants With at Least One Treatment-emergent Adverse Event [From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days]

    With at least one TEAE

  2. Best Corrected Visual Acuity [Baseline and Day 28]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients diagnosed with one chronic keratitis/corneal ulcer

  • Patients who signed and dated informed consent

Exclusion Criteria:
  • Patient under 18 years

  • Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Clinical Development DirectorClermont-FerrandFrance63000

Sponsors and Collaborators

  • Laboratoires Thea

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01794312
Other Study ID Numbers:
  • LT4020-PIII-12/11
First Posted:
Feb 18, 2013
Last Update Posted:
Oct 23, 2019
Last Verified:
Oct 1, 2019
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleT4020Vehicle
Arm/Group DescriptionOne drop every 2 daysOne drop every 2 days
Period Title: Overall Study
STARTED7478
COMPLETED6867
NOT COMPLETED611

Baseline Characteristics

Arm/Group TitleT4020VehicleTotal
Arm/Group DescriptionOne drop every 2 daysOne drop every 2 daysTotal of all reporting groups
Overall Participants7478152
Age (Count of Participants)
<=18 years
0
0%
1
1.3%
1
0.7%
Between 18 and 65 years
37
50%
32
41%
69
45.4%
>=65 years
37
50%
45
57.7%
82
53.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
62.2
(17)
65.2
(17.8)
63.8
(17.4)
Sex: Female, Male (Count of Participants)
Female
40
54.1%
42
53.8%
82
53.9%
Male
34
45.9%
36
46.2%
70
46.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
France
16
21.6%
20
25.6%
36
23.7%
Poland
12
16.2%
14
17.9%
26
17.1%
Turkey
8
10.8%
7
9%
15
9.9%
Belgium
6
8.1%
8
10.3%
14
9.2%
Italy
7
9.5%
6
7.7%
13
8.6%
Spain
7
9.5%
5
6.4%
12
7.9%
Greece
6
8.1%
6
7.7%
12
7.9%
Switzerland
4
5.4%
4
5.1%
8
5.3%
Netherlands
4
5.4%
4
5.1%
8
5.3%
Sweden
2
2.7%
1
1.3%
3
2%
United Kingdom
1
1.4%
2
2.6%
3
2%
Austria
0
0%
1
1.3%
1
0.7%
Portugal
1
1.4%
0
0%
1
0.7%

Outcome Measures

1. Primary Outcome
TitleNumber of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
DescriptionReduction in neurotrophic ulcer/keratitis area of 50% or more
Time FrameDay 28

Outcome Measure Data

Analysis Population Description
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
Arm/Group TitleT4020Vehicle
Arm/Group DescriptionOne drop every 2 daysOne drop every 2 days
Measure Participants7276
Count of Participants [Participants]
37
50%
44
56.4%
2. Secondary Outcome
TitleNumber of Participants With at Least One Treatment-emergent Adverse Event
DescriptionWith at least one TEAE
Time FrameFrom the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days

Outcome Measure Data

Analysis Population Description
Safety Set
Arm/Group TitleT4020Vehicle
Arm/Group DescriptionOne drop every 2 daysOne drop every 2 days
Measure Participants7478
Count of Participants [Participants]
25
33.8%
27
34.6%
3. Secondary Outcome
TitleBest Corrected Visual Acuity
DescriptionChange from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye
Time FrameBaseline and Day 28

Outcome Measure Data

Analysis Population Description
Safety set
Arm/Group TitleT4020Vehicle
Arm/Group DescriptionOne drop every 2 daysOne drop every 2 days
Measure Participants7478
Mean (Standard Deviation) [LogMAR]
-0.055
(0.362)
-0.035
(0.590)

Adverse Events

Time FrameFrom the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Adverse Event Reporting Description
Arm/Group TitleT4020Vehicle
Arm/Group DescriptionOne drop 4 times per weekOne drop 4 times per week
All Cause Mortality
T4020Vehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/74 (0%) 0/78 (0%)
Serious Adverse Events
T4020Vehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total3/74 (4.1%) 7/78 (9%)
Eye disorders
Ulcerative keratitis1/74 (1.4%) 10/78 (0%) 0
Keratitis1/74 (1.4%) 10/78 (0%) 0
Corneal neovascularisation0/74 (0%) 01/78 (1.3%) 1
Uveitis0/74 (0%) 01/78 (1.3%) 1
Corneal perforation0/74 (0%) 01/78 (1.3%) 1
Infections and infestations
Herpes Simplex ophthalmic1/74 (1.4%) 10/78 (0%) 0
Corneal infection0/74 (0%) 01/78 (1.3%) 1
Keratitis bacterial0/74 (0%) 01/78 (1.3%) 1
Injury, poisoning and procedural complications
Femoral neck fracture0/74 (0%) 01/78 (1.3%) 1
Surgical and medical procedures
Tooth extraction0/74 (0%) 01/78 (1.3%) 1
Other (Not Including Serious) Adverse Events
T4020Vehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total25/74 (33.8%) 27/78 (34.6%)
Eye disorders
Ulcerative keratitis3/74 (4.1%) 34/78 (5.1%) 4
Conjuncticitis allergic, diplopia1/74 (1.4%) 11/78 (1.3%) 1
Keratitis3/74 (4.1%) 31/78 (1.3%) 1
Eye pain0/74 (0%) 03/78 (3.8%) 3
Eye irritation2/74 (2.7%) 20/78 (0%) 0
Abnormal sensation in eye1/74 (1.4%) 10/78 (0%) 0
Acanthamoeba keratitis0/74 (0%) 01/78 (1.3%) 1
Conjunctival hemorrhage1/74 (1.4%) 10/78 (0%) 0
Conjunctivitis0/74 (0%) 01/78 (1.3%) 1
Conjunctivitis allergic1/74 (1.4%) 10/78 (0%) 0
Corneal epithelium defect0/74 (0%) 01/78 (1.3%) 1
Corneal erosion0/74 (0%) 01/78 (1.3%) 1
Corneal neovascularisation0/74 (0%) 01/78 (1.3%) 1
Corneal perforation0/74 (0%) 01/78 (1.3%) 1
Diplopia0/74 (0%) 01/78 (1.3%) 1
Dry eye0/74 (0%) 01/78 (1.3%) 1
Foreign body sensation in eyes1/74 (1.4%) 10/78 (0%) 0
Iridocyclitis1/74 (1.4%) 10/78 (0%) 0
Neurotrophic keratopathy1/74 (1.4%) 10/78 (0%) 0
Ocular hyperaemia0/74 (0%) 01/78 (1.3%) 1
Punctate keratitis1/74 (1.4%) 10/78 (0%) 0
Uveitis0/74 (0%) 01/78 (1.3%) 1
Vision blurred1/74 (1.4%) 10/78 (0%) 0
Visual acuity reduced1/74 (1.4%) 10/78 (0%) 0
Vitreous floaters1/74 (1.4%) 10/78 (0%) 0
General disorders
Instillation site reaction0/74 (0%) 01/78 (1.3%) 1
Influenza like illness0/74 (0%) 01/78 (1.3%) 1
Immune system disorders
Seasonal allergy0/74 (0%) 01/78 (1.3%) 1
Infections and infestations
Hypopyon, Keratitis bacterial, Keratitis herpetic, Corneal infection, Dacryocanaliculitis, Dacryocys3/74 (4.1%) 39/78 (11.5%) 9
Device related infection, Gastroenteritis, Oral herpes, Urinary tract infection4/74 (5.4%) 40/78 (0%) 0
Injury, poisoning and procedural complications
Femoral neck fracture, Road traffic accident1/74 (1.4%) 11/78 (1.3%) 1
Investigations
Vital dye staining cornea present0/74 (0%) 01/78 (1.3%) 1
Musculoskeletal and connective tissue disorders
Arthralgia0/74 (0%) 01/78 (1.3%) 1
Nervous system disorders
Headache0/74 (0%) 03/78 (3.8%) 3
Reproductive system and breast disorders
Begnin prostatic hyperplasia1/74 (1.4%) 10/78 (0%) 0
Skin and subcutaneous tissue disorders
Nail bed bleeding1/74 (1.4%) 10/78 (0%) 0
Surgical and medical procedures
Tooth extraction0/74 (0%) 01/78 (1.3%) 1
Vascular disorders
Hyperaemia0/74 (0%) 01/78 (1.3%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/TitleClinical Development Director
OrganizationLaboratoires Théa
Phone+33(0)473981414
EmailCorentin.LECAMUS@theapharma.com
Responsible Party:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01794312
Other Study ID Numbers:
  • LT4020-PIII-12/11
First Posted:
Feb 18, 2013
Last Update Posted:
Oct 23, 2019
Last Verified:
Oct 1, 2019