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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002947-27 | EudraCT Number |
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The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYL040012 (bamosiran) 0.375% eye drops | Experimental | 1 drop in each eye once daily for 28 consecutive days |
|
| SYL040012 (bamosiran) 0.750% eye drops | Experimental | 1 drop in each eye once daily for 28 consecutive days |
|
| SYL040012 (bamosiran) 1.125% eye drops | Experimental | 1 drop in each eye once daily for 28 consecutive days |
|
| SYL040012 (bamosiran) 1.5% eye drops | Experimental | 1 drop in each eye once daily for 28 consecutive days |
|
| Timolol maleate 0.5% ophthalmic solution | Active Comparator | 1 drop in each eye twice daily for 28 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 drop of 0.375% SYL040012 (bamosiran) | Drug |
| ||
| 1 drop of 0.750% SYL040012 (bamosiran) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm | Baseline and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm | Baseline and Day 14 | |
| Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm | The GQL-15 is a 15 item, 4-domain tool. GQL-15 scoring ranges from 0 to 75. Higher scores indicate poorer quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center | Artesia | California | 90701 | United States | ||
| North Bay Eye Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | SYL040012 (Bamosiran) 0.375% Eye Drops | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 0.375 % |
| FG001 | SYL040012 (Bamosiran) 0.750 % Eye Drops |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| 1 drop of 1.125% SYL040012 (bamosiran) | Drug |
|
| 1 drop of 1.5% SYL040012 (bamosiran) | Drug |
|
| 1 drop of 0.5 % timolol maleate | Drug |
|
| Baseline and Day 29 |
| Petaluma |
| California |
| 94954 |
| United States |
| Eye Care Centers Management, Inc (Clayton Eye Center) | Morrow | Georgia | 30260 | United States |
| Taustin Eye Center | Louisville | Kentucky | 40217 | United States |
| East Tallin Central Hospital | Tallinn | 10138 | Estonia |
| Eye Clinic Dr. Krista Turman | Tallinn | 13419 | Estonia |
| Tartu University Hospital | Tartu | 50406 | Estonia |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| University Clinic Magdeburg | Magdeburg | 39106 | Germany |
| Klinikum der Universität München | München | 80336 | Germany |
| Universitätsklinikum Münster | Münster | D-48149 | Germany |
| University Hospital Regensburg | Regensburg | 93053 | Germany |
| Hospital de Torrevieja | Torrevieja | Alicante | 03186 | Spain |
| Hospital de Jerez | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Clinica Universidad Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinic | Barcelona | 08036 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Complejo Hospitalario de Pontevedra | Pontevedra | 36001 | Spain |
| Instituto de Oftalmobiología Aplicada | Valladolid | 47011 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
1 drop in each eye once daily for 28 consecutive days
1 drop of SYL040012 (bamosiran) 0.750 %
| FG002 | SYL040012 (Bamosiran) 1.125% Eye Drops | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 1.125% |
| FG003 | SYL040012 (Bamosiran) 1.5% Eye Drops | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 1.5% |
| FG004 | Timolol Maleate 0.5% Ophthalmic Solution | 1 drop in each eye twice daily for 28 consecutive days 1 drop of timolol maleate: 0.5 % |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SYL040012 (Bamosiran) Eye Drops Dose A | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose A |
| BG001 | SYL040012 (Bamosiran) Eye Drops Dose B | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose B |
| BG002 | SYL040012 (Bamosiran) Eye Drops Dose C | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose C |
| BG003 | SYL040012 (Bamosiran) Eye Drops Dose D | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose D |
| BG004 | Timolol Maleate 0.5% Ophthalmic Solution | 1 drop in each eye twice daily for 28 consecutive days 1 drop of timolol maleate: 0.5 % |
| BG005 | 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 |
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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 | Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm | Posted | Mean | Standard Deviation | mmHg | Baseline and Day 28 |
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| Secondary | Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm | Posted | Mean | Standard Deviation | mmHg | Baseline and Day 14 |
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| Secondary | Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm | The GQL-15 is a 15 item, 4-domain tool. GQL-15 scoring ranges from 0 to 75. Higher scores indicate poorer quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 29 |
|
28 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 | SYL040012 (Bamosiran) Eye Drops Dose A | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose A | 0 | 37 | 0 | 37 | 4 | 37 |
| EG001 | SYL040012 (Bamosiran) Eye Drops Dose B | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose B | 0 | 40 | 0 | 40 | 9 | 40 |
| EG002 | SYL040012 (Bamosiran) Eye Drops Dose C | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose C | 0 | 37 | 0 | 37 | 6 | 37 |
| EG003 | SYL040012 (Bamosiran) Eye Drops Dose D | 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose D | 0 | 33 | 0 | 33 | 2 | 33 |
| EG004 | Timolol Maleate 0.5% Ophthalmic Solution | 1 drop in each eye twice daily for 28 consecutive days 1 drop of timolol maleate: 0.5 % | 0 | 37 | 0 | 37 | 2 | 37 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Instillation site pain | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Department | Sylentis | info@sylentis.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
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| Male |
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| Superiority |
| ANCOVA | 0.23 | Superiority |
| ANCOVA | 0.85 | Superiority |
| ANCOVA | 0.25 | Superiority |
| ANCOVA | 0.18 | Superiority |
|
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| Timolol Maleate 0.5% Ophthalmic Solution |
1 drop in each eye twice daily for 28 consecutive days 1 drop of timolol maleate: 0.5 % |
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