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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011157-41 | EudraCT Number |
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The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2345 | Experimental | One drop of T2345 |
|
| Prostaglandin | Active Comparator | One drop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2345 | Drug | One drop of T2345 |
| |
| Prostaglandin |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | The worse eye is defined as:
If both eyes have the same IOP at D0 the worse eye is the right eye. | Day 0 and Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Director | Clermont-Ferrand | 63000 | France |
Included patients= 404 patients but 2 patients without available data after Day 0. These 2 patients were excluded from the analyses sets.
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| ID | Title | Description |
|---|---|---|
| FG000 | T2345 | One drop of T2345 T2345: One drop of T2345 at 9.00pm |
| FG001 | Prostaglandin | One drop of prostaglandin Prostaglandin: One drop of prostaglandin at 9.00pm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set
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| ID | Title | Description |
|---|---|---|
| BG000 | T2345 | One drop of T2345 T2345: One drop of T2345 at 9.00pm. |
| BG001 | Prostaglandin | One drop of prostaglandin Prostaglandin: One drop of prostaglandin at 9.00pm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Intraocular Pressure (IOP) | The worse eye is defined as:
If both eyes have the same IOP at D0 the worse eye is the right eye. | mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye. | Posted | Mean | Standard Deviation | mmHg | Day 0 and Day 84 |
|
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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 | T2345 | One drop of T2345 T2345: One drop of T2345 at 9.00pm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tibia fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pascale Pouliquen - Medical Director | Laboratoires Théa | 33 473 981 436 | p.pouliquen@laboratoires-thea.fr |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D011453 | Prostaglandins |
| ID | Term |
|---|---|
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Drug |
One drop |
|
| Withdrawal by Subject |
|
| use of commercial drug instead of study |
|
| Non respect of one of inclusion criteria |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Prostaglandin |
One drop of prostaglandin Prostaglandin: One drop of prostaglandin at 9.00pm |
|
|
| 5 |
| 213 |
| 0 |
| 213 |
| EG001 | Prostaglandin | One drop of prostaglandin Prostaglandin: One drop of prostaglandin at 9.00pm | 1 | 189 | 0 | 189 |
| Major depression | Psychiatric disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | Non-systematic Assessment |
|
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.
| D012898 |
| Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |