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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilastine Ophthalmic Solution 0.6% | Experimental | Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period. |
|
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Active Comparator | Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period. |
|
| Vehicle of Bilastine Ophthalmic Solution | Placebo Comparator | Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilastine Ophthalmic Solution 0.6% | Drug | 1 drop in each eye at 2 separate times during an 8 day period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub). | The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea Consultants of AZ | Phoenix | Arizona | 85032 | United States | ||
| East West Eye Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36811846 | Derived | Gomes PJ, Ciolino JB, Arranz P, Hernandez G, Fernandez N. Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis. J Investig Allergol Clin Immunol. 2024 Jun 17;34(3):167-176. doi: 10.18176/jiaci.0894. Epub 2023 Feb 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilastine Ophthalmic Solution 0.6% | Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period. |
| FG001 | Ketotifen Ophthalmic Solution 0.025% (Zaditen) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 29, 2018 |
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| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Drug | 1 drop in each eye at 2 separate times during an 8 day period. |
|
|
| Vehicle of Bilastine Ophthalmic Solution | Drug | 1 drop in each eye at 2 separate times during an 8 day period. |
|
| Torrance |
| California |
| 90505 |
| United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Apex Eye | Mason | Ohio | 45040 | United States |
| Philadelphia Eye Associates | Philadelphia | Pennsylvania | 19134 | United States |
| Total Eye Care, P.A. | Memphis | Tennessee | 38119 | United States |
Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
| FG002 | Vehicle of Bilastine Ophthalmic Solution | Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilastine Ophthalmic Solution 0.6% | Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period. |
| BG001 | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period. |
| BG002 | Vehicle of Bilastine Ophthalmic Solution | Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. |
| BG003 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Ocular Itching- Baseline | The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment), using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub). The baseline measures for this primary outcome will be the "pre-CAC" values (Pre-Conjunctival Allergen Challenge). | Mean | Standard Deviation | units on a scale |
|
| 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 at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub). | Posted | Mean | Standard Deviation | units on a scale | The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment). |
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Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 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 Ophthalmic Solution 0.6% | Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period. | 0 | 91 | 0 | 91 | 4 | 91 |
| EG001 | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period. | 0 | 90 | 0 | 90 | 2 | 90 |
| EG002 | Vehicle of Bilastine Ophthalmic Solution | Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. | 0 | 47 | 0 | 47 | 1 | 47 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Acuty Reduced | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA 20.1 | 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 |
| 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 |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007665 | Ketotifen |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Visit 5: Pre-CAC |
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| Visit 4b: 7 minutes Post- CAC |
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| Visit 5: 3 minutes Post- CAC |
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| Visit 5: 5 minutes Post- CAC |
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| Visit 5: 7 minutes Post- CAC |
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Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).
| ANCOVA |
| < 0.0001 |
| Mean Difference (Final Values) |
| -1.167 |
| 2-Sided |
| 95 |
| -1.439 |
| -0.895 |
| Superiority |
| Treatment Difference (95% CI): Ketotifen Ophthalmic Solution 0.025% (Zaditen) arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points). | ANCOVA | < 0.0001 | Mean Difference (Final Values) | -1.140 | 2-Sided | 95 | -1.413 | -0.868 | Superiority |
| Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 3 minutes Post-CAC (non-inferiority test). | ANCOVA | 0.0007 | Mean Difference (Final Values) | 0.009 | 1-Sided | 97.5 | 0.235 | Non-Inferiority | Non-inferiority margin of 0.40 |
| Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 5 minutes Post-CAC (non-inferiority test). | ANCOVA | 0.0002 | Mean Difference (Final Values) | -0.077 | 1-Sided | 97.5 | 0.175 | Non-Inferiority | Non-inferiority margin of 0.40 |
| Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 7 minutes Post-CAC (non-inferiority test). | ANCOVA | < 0.0001 | Mean Difference (Final Values) | -0.159 | 1-Sided | 97.5 | 0.101 | Non-Inferiority | Non-inferiority margin of 0.40 |