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The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostaglandin | Active Comparator | One drop. |
|
| T2345 | Experimental | One drop |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2345 | Drug | One drop at 8.00pm. |
| |
| Prostaglandin |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intra Ocular Pressure (IOP) at 8.00am | Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered. | Day 42 and Day 84 (8.00am for the IOP) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27310103 | Derived | Aptel F, Choudhry R, Stalmans I. Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension. Curr Med Res Opin. 2016 Aug;32(8):1457-63. doi: 10.1080/03007995.2016.1202818. Epub 2016 Jun 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prostaglandin/T2345 | One drop at 8.00pm. |
| FG001 | T2345/Prostaglandin | One drop at 8.00pm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Day0-Day42 |
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| Drug |
One drop at 8.00pm. |
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| COMPLETED |
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| NOT COMPLETED |
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| Day42-Day84 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prostaglandin/T2345 | One drop at 8.00pm. |
| BG001 | T2345/Prostaglandin | One drop at 8.00pm. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Mean Intra Ocular Pressure (IOP) at 8.00am | Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered. | Per protocol (PP) set: All patients enrolled in the study for whom any follow-up efficacy information was evaluable and who did not show any major protocol deviation that could affect the efficacy assessment. | Posted | Mean | Standard Deviation | mmHg | Day 42 and Day 84 (8.00am for the IOP) |
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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 | Prostaglandin | One drop at 8.00pm. | 0 | 30 | 0 | 30 | ||
| EG001 | T2345 | One drop at 8.00pm. | 1 | 30 | 0 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Status Asthmaticus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pascale Pouliquen - Medical Director | Laboratoires Théa | 33 473 981 436 | p.pouliquen@laboratoires-thea.fr |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| 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 |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Male |
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