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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilastine 0.2% | Experimental | Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period. |
|
| Bilastine 0.4% | Experimental | Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period. |
|
| Bilastine 0.6% | Experimental | Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period. |
|
| Bilastine 0% | Placebo Comparator | Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilastine 0.2% | Drug | 1 drop in each eye at 3 separate times during a 25 day period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch. | The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora Clinical Research Center | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilastine 0.2% | Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period. |
| FG001 | Bilastine 0.4% | Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period. |
| FG002 | Bilastine 0.6% | Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period. |
| FG003 | Bilastine 0% | Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilastine 0.2% | Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period. |
| BG001 | Bilastine 0.4% | Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Ocular Itching | The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch. | Posted | Mean | Standard Deviation | units on a scale | The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment). |
|
Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 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 | Bilastine 0.2% | Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Acuity Reduced | Eye disorders | MedDRA version 20.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nieves Fernández, MD, PhD | Faes Farma | +34 94 481 83 00 | nfernandez@faes.es |
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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 | Jun 28, 2017 | Mar 15, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Bilastine 0.4% |
| Drug |
1 drop in each eye at 3 separate times during a 25 day period. |
|
| Bilastine 0.6% | Drug | 1 drop in each eye at 3 separate times during a 25 day period. |
|
| Bilastine 0% | Drug | 1 drop in each eye at 3 separate times during a 25 day period. |
|
| BG002 | Bilastine 0.6% | Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period. |
| BG003 | Bilastine 0% | Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Ocular Itching- Baseline | The primary efficacy measure was ocular itching evaluated by the subject post-CAC at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment), using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.The baseline measures for this primary outcome will be the "pre-CAC" values (pre-Conjunctival Allergen Challenge). | Mean | Standard Deviation | units on a scale |
|
| OG002 | Bilastine 0.6% | Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period. |
| OG003 | Bilastine 0% (Vehicle) | Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 8 |
| 30 |
| EG001 | Bilastine 0.4% | Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period. | 0 | 30 | 0 | 30 | 3 | 30 |
| EG002 | Bilastine 0.6% | Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period. | 0 | 31 | 0 | 31 | 1 | 31 |
| EG003 | Bilastine 0% | Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period. | 0 | 30 | 0 | 30 | 7 | 30 |
| Blepharitis | Eye disorders | MedDRA version 20.0 | Non-systematic Assessment |
|
| Corneal Deposits | Eye disorders | MedDRA version 20.0 | Non-systematic Assessment |
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| Eye Discharge | Eye disorders | MedDRA version 20.0 | Non-systematic Assessment |
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| Keratitis | Eye disorders | MedDRA version 20.0 | Non-systematic Assessment |
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| Macular Fibrosis | Eye disorders | MedDRA version 20.0 | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
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| Gastroenteritis Viral | Infections and infestations | MedDRA version 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 20.0 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA version 20.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 20.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 20.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 20.0 | Non-systematic Assessment |
|
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |