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This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2 study evaluating the safety and tolerability of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD and BID for the treatment of acute exacerbations of blepharitis. The study will be performed in two sequential dose escalating cohorts.
The study is designed to select the dose(s) of NCX 4251 to advance into the next stage of development, and to assess the safety and tolerability of NCX 4251 Ophthalmic Suspension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCX 4251 QD | Experimental | NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days |
|
| Placebo QD | Placebo Comparator | Placebo once daily for 14 days |
|
| NCX 4251 BID | Experimental | NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days |
|
| Placebo BID | Placebo Comparator | Placebo twice daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate | Drug | NCX 4251 Ophthalmic Suspension, 0.1% |
|
| Measure | Description | Time Frame |
|---|---|---|
| COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | COHORT 1 and 2 COMBINED: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | COHORT 2: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) | 14 days |
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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 |
|---|---|---|---|---|---|---|
| Texan Eye | Austin | Texas | 78731 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NCX 4251 QD -- Cohort 1 | NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% |
| FG001 | Placebo QD -- Cohort 1 | Placebo once daily for 14 days Placebo: NCX 4251 Ophthalmic Suspension, 0% |
| FG002 | NCX 4251 BID -- Cohort 2 | NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% |
| FG003 | Placebo BID -- Cohort 2 | Placebo twice daily for 14 days Placebo: NCX 4251 Ophthalmic Suspension, 0% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The primary outcome measure was based on the study eye
| ID | Title | Description |
|---|---|---|
| BG000 | NCX 4251 QD (Cohort 1) | NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% |
| BG001 | Placebo QD (Cohort 1) |
| 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 | COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | COHORT 1 and 2 COMBINED: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) | intent-to-treat population | Posted | Mean | Full Range | units on a scale | 14 days | study eyes | study eyes |
|
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 | NCX 4251 QD | NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eyelid margin crusting | Eye disorders | MedDRA 22.0 | 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 | Aug 13, 2019 | Sep 21, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2019 | 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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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
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double-masked
| Placebo | Drug | NCX 4251 Ophthalmic Suspension, 0% |
|
| COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis |
COHORT 1: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) |
| 14 days |
Placebo once daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
| BG002 | NCX 4251 QD (Cohort 2) | NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% |
| BG003 | Placebo QD (Cohort 2) | Placebo twice daily for 14 days Placebo: NCX 4251 Ophthalmic Suspension, 0% |
| BG004 | Total | Total of all reporting groups |
| study eyes |
|
| Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Composite score of eyelid discomfort, eyelid margin redness, and debris | Eyelid margin discomfort (0=none to 3=severe) + eyelid margin redness (0=none/normal to 3=severe) + debris (0=none to 3=severe) for a composite total score ranging from 0 to 9. Eyelid margin discomfort reported by the participant; eyelid margin redness and eyelid debris evaluated by the investigator at the slit lamp. | Mean | Full Range | units on a scale | Participants |
|
Placebo once or twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
|
|
| Secondary | COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | COHORT 2: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) | intent-to-treat population | Posted | Mean | Full Range | units on a scale | 14 days | study eyes | study eyes |
|
|
|
| Secondary | COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | COHORT 1: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) | intent-to-treat population | Posted | Mean | Full Range | units on a scale | 14 days | study eyes | study eyes |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Placebo QD | Placebo once daily for 14 days Placebo: NCX 4251 Ophthalmic Suspension, 0% | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | NCX 4251 BID | NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% | 0 | 10 | 0 | 10 | 5 | 10 |
| EG003 | Placebo BID | Placebo twice daily for 14 days Placebo: NCX 4251 Ophthalmic Suspension, 0% | 0 | 11 | 0 | 11 | 0 | 11 |
| periorbital oedema | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| conjunctival hemorrhage | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| instillation site pruritus | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |