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The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCX 470 0.021% | Experimental | NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks |
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| NCX 470 0.042% | Experimental | NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks |
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| NCX 470 0.065% | Experimental | NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks |
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| Latanoprost 0.005% | Active Comparator | Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCX 470 | Drug | NCX 470 Ophthalmic Solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4 | Participants used medication in both eyes for 4 weeks with one eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP at week 4 is the average of the 8AM, 10AM and 4PM IOPs at week 4. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit | Participants used medication in both eyes from baseline to the evening prior to the week 4 visit. One eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP is the average of the 8AM, 10AM and 4PM values. Visits were conducted at week 1, week 2, week 4, and an exit visit (1 to 2 days following the week 4 visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicox Ophthalmics, Inc. | Nicox Ophthalmics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texan Eye | Austin | Texas | 78731 | United States |
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Potential participants were screened for eligibility and those on intraocular pressure (IOP) lowering medication were required to undergo a wash out of 5 to 42 days (dependent on the class of medication). After the appropriate washout period, or after a minimum of 5 days for participants who were not on IOP lowering medication at screening, participants underwent 2 eligibility visits held 3 to 7 days apart. Those who qualified were randomized to one of the 4 treatment groups.
Participants were recruited from ophthalmologists' clinics in the US. The first participant for the study was screened in August 2018 and the last participant exited the trial in August 2019.
| ID | Title | Description |
|---|---|---|
| FG000 | NCX 470 0.021% | NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution |
| FG001 | NCX 470 0.042% | NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution |
| 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 | Yes | No | No | Study Protocol | Oct 23, 2018 | Nov 6, 2022 |
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| Latanoprost 0.005% | Drug | Latanoprost 0.005% Ophthalmic Solution |
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| Baseline, week 1, week 2, exit visit |
| Percentage of Subjects With Treatment-emergent Ocular Adverse Events | Safety and tolerability based on percentage of subjects with treatment-emergent ocular adverse events | 4 weeks for adverse events and through 30 days post-treatment for serious adverse events |
| FG002 | NCX 470 0.065% | NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution |
| FG003 | Latanoprost 0.005% | Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks Latanoprost 0.005%: Latanoprost 0.005% Ophthalmic Solution |
| COMPLETED |
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| NOT COMPLETED |
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Participants contribute a study eye (fellow eye also treated)
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| ID | Title | Description |
|---|---|---|
| BG000 | NCX 470 0.021% | NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution |
| BG001 | NCX 470 0.042% | NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution |
| BG002 | NCX 470 0.065% | NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution |
| BG003 | Latanoprost 0.005% | Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks Latanoprost 0.005%: Latanoprost 0.005% Ophthalmic Solution |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| 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 |
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| Region of Enrollment | Count of Participants | Participants |
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| Study Eye Baseline Mean Diurnal IOP (mmHg) | Average of study eye IOP measured at 8AM,10AM and 4PM at 2 eligibility visits | Mean | Standard Deviation | mmHg |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4 | Participants used medication in both eyes for 4 weeks with one eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP at week 4 is the average of the 8AM, 10AM and 4PM IOPs at week 4. | All participants who were randomized and who had diurnal IOP values at week 4 | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 4 | study eyes | study eyes |
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| Secondary | Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit | Participants used medication in both eyes from baseline to the evening prior to the week 4 visit. One eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP is the average of the 8AM, 10AM and 4PM values. Visits were conducted at week 1, week 2, week 4, and an exit visit (1 to 2 days following the week 4 visit) | All participants who were randomized and who had diurnal IOP values at the week 1, week 2, exit visits | Posted | Mean | Standard Deviation | mmHg | Baseline, week 1, week 2, exit visit | study eyes | study eyes |
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| Secondary | Percentage of Subjects With Treatment-emergent Ocular Adverse Events | Safety and tolerability based on percentage of subjects with treatment-emergent ocular adverse events | Safety population defined as all participants who received at least one dose of the study medication during the 4-week treatment period | Posted | Count of Participants | Participants | 4 weeks for adverse events and through 30 days post-treatment for serious adverse events |
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29 days with collection of serious adverse events for up to 30 days post study exit
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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 470 0.021% | NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution | 0 | 111 | 1 | 111 | 24 | 111 |
| EG001 | NCX 470 0.042% | NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution | 0 | 108 | 2 | 108 | 42 | 108 |
| EG002 | NCX 470 0.065% | NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution | 0 | 107 | 1 | 107 | 39 | 107 |
| EG003 | Latanoprost 0.005% | Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks Latanoprost 0.005%: Latanoprost 0.005% Ophthalmic Solution | 0 | 107 | 0 | 107 | 20 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
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| Endophthalmitis | Eye disorders | MedDRA 21.0 | Non-systematic Assessment | acute unspecified purulent endophthalmitis following cataract surgery in the 30-day period following completion of study treatment |
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| Hypertension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment | Worsening of hypertension |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Instillation site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Instillation site pruritus | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Hubatsch / Chief Scientific Officer | Nicox Ophthalmics Inc. | 832-360-3022 | hubatsch@nicox.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2019 | Nov 6, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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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 |
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| 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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| study eyes |
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| NCX 0.042% was compared to latanoprost. | ANCOVA | 0.0281 | p-value was not adjusted for multiple comparisons | Mean Difference (Final Values) | -0.81 | 2-Sided | 95 | -1.52 | -0.09 | Non-Inferiority | LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was < 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was <= 0.05 and the LS mean difference in change from baseline was < 0. |
| NCX 0.065% was compared to latanoprost. | ANCOVA | 0.0009 | p-value was not adjusted for multiple comparisons | Mean Difference (Final Values) | -1.23 | 2-Sided | 95 | -1.96 | -0.51 | Non-Inferiority | LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was < 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was <= 0.05 and the LS mean difference in change from baseline was < 0. |
| Latanoprost 0.005% |
Participants received latanoprost 0.005% once daily in both eyes |
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