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The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T4020 | Experimental | 1 drop every other day during 5 days |
|
| Saline solution | Placebo Comparator | 1 drop every other day during 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T4020 | Device |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 | Day 3 | |
| Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Epithelial Defect Size Assessment | Baseline and Day 5 | |
| Number of Participants With Treatment-emergent Adverse Events | Through study completion, an average of 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital | Varna | Bulgaria | ||||
| CHU |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | T4020 | 1 drop every other day during 5 days T4020 |
| FG001 | Saline Solution | 1 drop every other day during 5 days Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T4020 | 1 drop every other day during 5 days T4020 |
| BG001 | Saline Solution | 1 drop every other day during 5 days Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set. |
| 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 Complete Healing of Corneal Epithelial Defect at Day 3 | 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. | Posted | Count of Participants | Participants | Day 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.
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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 | 1 drop every other day during 5 days T4020 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment | Ocular adverse event |
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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 | Sep 2, 2016 | Jul 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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|
| Clermont-Ferrand |
| 63000 |
| France |
| Hospital | Vigo | Spain |
| Erciyes Üniversitesi Tıp Fakültesi | Kayseri | Turkey (Türkiye) |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set. | 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 | 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set. | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 | 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. | Posted | Count of Participants | Participants | Day 4 |
|
|
|
| Secondary | Corneal Epithelial Defect Size Assessment | 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. | Posted | Mean | Standard Deviation | mm^2 | Baseline and Day 5 |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events | Safety set (137 treated participants) | Posted | Count of Participants | Participants | Through study completion, an average of 1 month |
|
|
|
| 73 |
| 0 |
| 73 |
| 12 |
| 73 |
| EG001 | Saline Solution | 1 drop every other day during 5 days Placebo | 0 | 64 | 0 | 64 | 8 | 64 |
| Malabsorption from application site | General disorders | Systematic Assessment | Ocular adverse events |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment | Ocular adverse event |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Systemic Non Ocular adverse event |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment | Systemic Non Ocular adverse event |
|
| Procedural nausea | Injury, poisoning and procedural complications | Systematic Assessment | Systemic Non Ocular adverse event |
|
| Headache | Nervous system disorders | Systematic Assessment | Systemic Non Ocular adverse event |
|
| Contact lens intolerance | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Corneal disorder | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Corneal infiltrates | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Corneal oedema | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Corneal opacity | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Eye pain | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Eyelid oedema | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Keratitis | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Ocular discomfort | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Punctate keratitis | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Vision blurred | Eye disorders | Systematic Assessment | Ocular adverse event |
|
| Eye infection | Infections and infestations | Systematic Assessment | Ocular adverse event |
|
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.