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The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T4020 | Experimental | One drop every 2 days |
|
| Vehicle | Placebo Comparator | One drop every 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T4020 | Device |
| ||
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 | Reduction in neurotrophic ulcer/keratitis area of 50% or more | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment-emergent Adverse Event | With at least one TEAE | From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days |
| Best Corrected Visual Acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Development Director | Clermont-Ferrand | 63000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | T4020 | One drop every 2 days |
| FG001 | Vehicle | One drop every 2 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T4020 | One drop every 2 days |
| BG001 | Vehicle | One drop every 2 days |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 | Reduction in neurotrophic ulcer/keratitis area of 50% or more | 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 | Posted | Count of Participants | Participants | Day 28 |
|
From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T4020 | One drop 4 times per week | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative keratitis | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative keratitis | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Director | Laboratoires Théa | +33(0)473981414 | Corentin.LECAMUS@theapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2015 | Jul 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007634 | Keratitis |
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015817 | Eye Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014677 | Pharmaceutical Vehicles |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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|
Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye
| Baseline and Day 28 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With at Least One Treatment-emergent Adverse Event | With at least one TEAE | Safety Set | Posted | Count of Participants | Participants | From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days |
|
|
|
| Secondary | Best Corrected Visual Acuity | Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye | Safety set | Posted | Mean | Standard Deviation | LogMAR | Baseline and Day 28 |
|
|
|
| 74 |
| 3 |
| 74 |
| 25 |
| 74 |
| EG001 | Vehicle | One drop 4 times per week | 0 | 78 | 7 | 78 | 27 | 78 |
| Herpes Simplex ophthalmic | Infections and infestations | Systematic Assessment |
|
| Keratitis | Eye disorders | Systematic Assessment |
|
| Corneal neovascularisation | Eye disorders | Systematic Assessment |
|
| Corneal infection | Infections and infestations | Systematic Assessment |
|
| Uveitis | Eye disorders | Systematic Assessment |
|
| Corneal perforation | Eye disorders | Systematic Assessment |
|
| Keratitis bacterial | Infections and infestations | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
|
| Hypopyon, Keratitis bacterial, Keratitis herpetic, Corneal infection, Dacryocanaliculitis, Dacryocys | Infections and infestations | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Instillation site reaction | General disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Vital dye staining cornea present | Investigations | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Hyperaemia | Vascular disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Conjuncticitis allergic, diplopia | Eye disorders | Systematic Assessment | Ocular adverse event in the other eye |
|
| Device related infection, Gastroenteritis, Oral herpes, Urinary tract infection | Infections and infestations | Systematic Assessment | Non ocular adverse event |
|
| Headache | Nervous system disorders | Systematic Assessment | Non ocular adverse event |
|
| Femoral neck fracture, Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment | Non ocular adverse event |
|
| Influenza like illness | General disorders | Systematic Assessment | Non ocular adverse event |
|
| Seasonal allergy | Immune system disorders | Systematic Assessment | Non ocular adverse event |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Non ocular adverse event |
|
| Begnin prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment | Non ocular adverse event |
|
| Nail bed bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment | Non ocular adverse event |
|
| Tooth extraction | Surgical and medical procedures | Systematic Assessment | Non ocular adverse event |
|
| Keratitis | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Eye pain | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Eye irritation | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Abnormal sensation in eye | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Acanthamoeba keratitis | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Conjunctival hemorrhage | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Conjunctivitis | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Conjunctivitis allergic | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Corneal epithelium defect | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Corneal erosion | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Corneal neovascularisation | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Corneal perforation | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Diplopia | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Dry eye | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Foreign body sensation in eyes | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Iridocyclitis | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Neurotrophic keratopathy | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Punctate keratitis | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Uveitis | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Vision blurred | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Visual acuity reduced | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
| Vitreous floaters | Eye disorders | Systematic Assessment | Ocular adverse event in pathologic eye |
|
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.
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |