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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017388-41 | EudraCT Number |
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| Name | Class |
|---|---|
| Keyrus Biopharma | OTHER |
| VEEDA | UNKNOWN |
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The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).
Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin.
Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times.
Efficacy will be evaluated by change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort evaluation (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unifluid | Placebo Comparator | Eye drops in Single Dose Unit |
|
| Azithromycin | Experimental | Eye drops Single dose unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Eye drops, Dosage : 1.5% 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS - Ranges 0-100 mm) | The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome) | Baseline and D63 (D63 minus baseline) |
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Inclusion Criteria:
-Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe BAUDOUIN, Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H.N.O des XV-XX | Paris | 75012 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unifluid | Eye drops in Single Dose Unit Povidone: Eye drops Single dose unit 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. |
| FG001 | Azithromycin | Eye drops Single dose unit Azithromycin: Eye drops, Dosage : 1.5% 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unifluid | Eye drops in Single Dose Unit Povidone: Eye drops Single dose unit 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. |
| BG001 | Azithromycin |
| 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 | Visual Analogue Scale (VAS - Ranges 0-100 mm) | The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome) | Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale (from 0 to 100 mm) | Baseline and D63 (D63 minus baseline) |
|
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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 | Unifluid | Eye drops in Single Dose Unit Povidone: Eye drops Single dose unit 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pascale POULIQUEN | Laboratoires Thea | 0473981436 | p.pouliquen@laboratoires-thea.fr |
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| ID | Term |
|---|---|
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D011205 | Povidone |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| Povidone | Drug | Eye drops Single dose unit 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. |
|
|
Eye drops Single dose unit Azithromycin: Eye drops, Dosage : 1.5% 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Azithromycin |
Eye drops Single dose unit Azithromycin: Eye drops, Dosage : 1.5% 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Azithromycin | Eye drops Single dose unit Azithromycin: Eye drops, Dosage : 1.5% 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. | 0 | 50 | 0 | 50 |
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.
| Organic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |