A Phase 2 interventional study of NCX 4251 and Placebo in Blepharitis, sponsored by Nicox Ophthalmics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Nicox Ophthalmics, Inc. · Phase 2, Interventional, and Treatment
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 224 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Nicox Ophthalmics, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NCX 4251 Ophthalmic Suspension
Drug: NCX 4251
Vehicle of NCX 4251 Ophthalmic Suspension
Drug: Placebo
NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
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
Time frame: Day 15 Visit
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
Time frame: Day 15 Visit
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
Time frame: 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)
Time frame: 29 days
eyecare practictioners' practices
| Milestone | NCX 4251 | Placebo |
|---|---|---|
| Started | 111 | 113 |
| Completed | 109 | 112 |
| Not completed | 2 | 1 |
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
| study eyes | NCX 4251 | Placebo |
|---|---|---|
| Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 | 4 | 2 |
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
| units on a scale | NCX 4251 | Placebo |
|---|---|---|
| Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms | -16.4 (-20.7 to -12.0) | -12.5 (-16.5 to -8.5) |
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
| units on a scale | NCX 4251 | Placebo |
|---|---|---|
| Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea) | -0.18 (-0.34 to -0.02) | -0.13 (-0.26 to 0.01) |
Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)
| Participants | NCX 4251 | Placebo |
|---|---|---|
| Treatment-emergent Adverse Events | 12 | 17 |
Collected over 29 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NCX 4251 | 0/111 (0%) | 0/111 (0%) | 12/111 (10.8%) |
| Placebo | 0/113 (0%) | 0/113 (0%) | 20/113 (17.7%) |
| Event | NCX 4251 | Placebo |
|---|---|---|
| Instillation site painGeneral disorders | 1/111 | 5/113 |
| Visual acuity reducedEye disorders | 1/111 | 2/113 |
| Eye pruritusEye disorders | 1/111 | 1/113 |
| Vitreous detachmentEye disorders | 1/111 | 1/113 |
| Eyelids pruritusEye disorders | 1/111 | 0/113 |
| PapillomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/111 | 0/113 |
| Conjunctival hyperaemiaEye disorders | 1/111 | 0/113 |
| Procedural painInjury, poisoning and procedural complications | 1/111 | 0/113 |
| SplinterInjury, poisoning and procedural complications | 1/111 | 0/113 |
| Back painMusculoskeletal and connective tissue disorders | 1/111 | 1/113 |
Study Eye
| Age, Categorical(Participants) | NCX 4251 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 63 | 50 | 113 |
| >=65 years | 48 | 63 | 111 |
| Age, Continuous(years) | NCX 4251 | Placebo | Total |
|---|---|---|---|
| Mean | 61.4 ± 13.75 | 63.2 ± 14.31 | 62.3 ± 14.03 |
| Sex: Female, Male(Participants) | NCX 4251 | Placebo | Total |
|---|---|---|---|
| Female | 75 | 67 | 142 |
| Male | 36 | 46 | 82 |
| Ethnicity (NIH/OMB)(Participants) | NCX 4251 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 8 | 13 |
| Not Hispanic or Latino | 106 | 105 | 211 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NCX 4251 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 26 | 21 | 47 |
| White | 84 | 87 | 171 |
| More than one race | 0 | 3 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | NCX 4251 | Placebo | Total |
|---|---|---|---|
| United States | 111 | 113 | 224 |
| Composite Score of Eyelid Margin Redness + Eyelid Debris + Eyelid Discomfort in the study eye(units on a scale for study eyes) | NCX 4251 | Placebo | Total |
|---|---|---|---|
| Mean | 4.6 (3 to 8) | 4.7 (3 to 7) | 4.7 (3 to 7) |
| Eye Dryness(units on a scale for study eyes) | NCX 4251 | Placebo | Total |
|---|---|---|---|
| Mean | 59.1 (4 to 99) | 57.5 (0 to 99) | 58.3 (0 to 99) |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Jun 2021, 6 months.
Results were first posted in Dec 2022, 1 year 5 months after primary completion.
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Nicox Ophthalmics, Inc.