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This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2b trial evaluating the safety and efficacy of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD for the treatment of acute exacerbations of blepharitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCX 4251 | Experimental | NCX 4251 Ophthalmic Suspension |
|
| Placebo | Placebo Comparator | Vehicle of NCX 4251 Ophthalmic Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCX 4251 | Drug | NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 | Percentage of study eyes with Complete Cure (Score 0) in each of the following: Eyelid Margin Redness (0-none, 1-mild, 2-moderate, 3-severe), Eyelid Debris (0-none, 1-mild, 2-moderate, 3-severe), and Eyelid Discomfort (0-none, 1-mild, 2-moderate, 3-severe) at the Day 15 Visit | Day 15 Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms | Mean change from baseline in the eye dryness symptoms using a visual analogue scale (0 = no discomfort to 100 = maximal discomfort) at the Day 15 Visit | Day 15 Visit |
| Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicox Ophthalmics | Nicox Ophthalmics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
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7 to 14 day screening period
eyecare practictioners' practices
| ID | Title | Description |
|---|---|---|
| FG000 | NCX 4251 | NCX 4251 Ophthalmic Suspension NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily |
| FG001 | Placebo | Vehicle of NCX 4251 Ophthalmic Suspension Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study Eye
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| ID | Title | Description |
|---|---|---|
| BG000 | NCX 4251 | NCX 4251 Ophthalmic Suspension NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily |
| BG001 | Placebo | Vehicle of NCX 4251 Ophthalmic Suspension Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily |
| 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 | Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 | Percentage of study eyes with Complete Cure (Score 0) in each of the following: Eyelid Margin Redness (0-none, 1-mild, 2-moderate, 3-severe), Eyelid Debris (0-none, 1-mild, 2-moderate, 3-severe), and Eyelid Discomfort (0-none, 1-mild, 2-moderate, 3-severe) at the Day 15 Visit | Intent to treat (for study eyes with data for all 3 scales at the Baseline and Day 15 Visit) | Posted | Count of Units | study eyes | Day 15 Visit | study eyes | study eyes |
|
29 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 | NCX 4251 | NCX 4251 Ophthalmic Suspension NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Hubatsch | Nicox Ophthalmics, Inc. | 832-360-3022 | hubatsch@nicox.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2021 | Sep 21, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 4, 2021 | Sep 21, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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double-masked
| Placebo |
| Drug |
Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily |
|
Mean change from baseline in study eye fluorescein staining score (score of 0=none, 1=trace, 2=mild, 3=moderate, 4=severe) of the inferior cornea at the Day 15 Visit |
| Day 15 Visit |
| Treatment-emergent Adverse Events | Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated) | 29 days |
| BG002 | 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 |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Composite Score of Eyelid Margin Redness + Eyelid Debris + Eyelid Discomfort in the study eye | Composite (sum) score of Eyelid Margin Redness (0=none to 3=severe), Eyelid Debris (0=none to 3=severe), and Eyelid Discomfort (0=none to 3=severe) in the study eye | Mean | Full Range | units on a scale for study eyes |
|
| Eye Dryness | visual analog scale (0=no discomfort to 100=maximal discomfort) | Mean | Full Range | units on a scale for study eyes |
|
| Inferior Cornea Staining Score | Fluorescein staining scale (0=none to 4=severe) | Mean | Full Range | units on a scale for study eyes |
|
Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
|
|
| Secondary | Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms | Mean change from baseline in the eye dryness symptoms using a visual analogue scale (0 = no discomfort to 100 = maximal discomfort) at the Day 15 Visit | intent to treat (in study eyes with data at Baseline and Day 15 Visit) | Posted | Mean | 95% Confidence Interval | units on a scale | Day 15 Visit | study eyes | study eyes |
|
|
|
|
| Secondary | Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea) | Mean change from baseline in study eye fluorescein staining score (score of 0=none, 1=trace, 2=mild, 3=moderate, 4=severe) of the inferior cornea at the Day 15 Visit | intent to treat (for study eyes with data at Baseline and Day 15) | Posted | Mean | 95% Confidence Interval | units on a scale | Day 15 Visit | study eyes | study eyes |
|
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|
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| Secondary | Treatment-emergent Adverse Events | Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated) | Safety population (all randomized subjects who received at least one dose of the intervention) | Posted | Count of Participants | Participants | 29 days |
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| 0 |
| 111 |
| 0 |
| 111 |
| 12 |
| 111 |
| EG001 | Placebo | Vehicle of NCX 4251 Ophthalmic Suspension Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily | 0 | 113 | 0 | 113 | 20 | 113 |
| Eye pruritus | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Eyelid irritation | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Eyelids pruritus | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Instillation site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Instillation site oedema | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Splinter | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Stress fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Ageusia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
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