A Phase 2 interventional study of Fluticasone Propionate 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 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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 36 is below 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, 0.1% once daily for 14 days
Drug: Fluticasone Propionate
Placebo once daily for 14 days
Drug: Placebo
NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Drug: Fluticasone Propionate
Placebo twice daily for 14 days
Drug: Placebo
NCX 4251 Ophthalmic Suspension, 0.1%
Also known as: NCX 4251
NCX 4251 Ophthalmic Suspension, 0%
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)
Time frame: 14 days
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)
Time frame: 14 days
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)
Time frame: 14 days
| Milestone | NCX 4251 QD -- Cohort 1 | Placebo QD -- Cohort 1 | NCX 4251 BID -- Cohort 2 | Placebo BID -- Cohort 2 |
|---|---|---|---|---|
| Started | 10 | 5 | 10 | 11 |
| Completed | 10 | 5 | 10 | 11 |
| Not completed | 0 | 0 | 0 | 0 |
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)
| units on a scale | NCX 4251 (Cohort 1 & 2 Combined) | Placebo (Cohort 1 & 2 Combined) |
|---|---|---|
| COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -2.0 (-4 to 1) | -1.2 (-2 to 1) |
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)
| units on a scale | NCX 4251 BID (Cohort 2) | Placebo BID (Cohort 2) |
|---|---|---|
| COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -1.7 (-3 to -1) | -1.1 (-2 to 1) |
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)
| units on a scale | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) |
|---|---|---|
| COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -2.2 (-4 to 1) | -1.2 (-2 to 0) |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NCX 4251 QD | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Placebo QD | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| NCX 4251 BID | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Placebo BID | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Event | NCX 4251 QD | Placebo QD | NCX 4251 BID | Placebo BID |
|---|---|---|---|---|
| conjunctival hemorrhageEye disorders | 0/10 | 0/5 | 3/10 | 0/11 |
| eyelid margin crustingEye disorders | 1/10 | 0/5 | 0/10 | 0/11 |
| periorbital oedemaEye disorders | 1/10 | 0/5 | 0/10 | 0/11 |
| pruritusSkin and subcutaneous tissue disorders | 1/10 | 0/5 | 0/10 | 0/11 |
| instillation site pruritusGeneral disorders | 0/10 | 0/5 | 1/10 | 0/11 |
| upper respiratory tract infectionInfections and infestations | 0/10 | 0/5 | 1/10 | 0/11 |
The primary outcome measure was based on the study eye
| Age, Categorical(Participants) | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) | NCX 4251 QD (Cohort 2) | Placebo QD (Cohort 2) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 1 | 5 | 5 | 15 |
| >=65 years | 6 | 4 | 5 | 6 | 21 |
| Age, Continuous(years) | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) | NCX 4251 QD (Cohort 2) | Placebo QD (Cohort 2) | Total |
|---|---|---|---|---|---|
| Mean | 63.5 (28 to 84) | 67.8 (48 to 88) | 58.3 (28 to 84) | 64.5 (48 to 78) | 65.4 (28 to 88) |
| Sex: Female, Male(Participants) | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) | NCX 4251 QD (Cohort 2) | Placebo QD (Cohort 2) | Total |
|---|---|---|---|---|---|
| Female | 7 | 2 | 7 | 5 | 21 |
| Male | 3 | 3 | 3 | 6 | 15 |
| Ethnicity (NIH/OMB)(Participants) | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) | NCX 4251 QD (Cohort 2) | Placebo QD (Cohort 2) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 | 1 | 3 |
| Not Hispanic or Latino | 9 | 5 | 9 | 10 | 33 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) | NCX 4251 QD (Cohort 2) | Placebo QD (Cohort 2) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 0 | 1 |
| White | 10 | 5 | 9 | 11 | 35 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) | NCX 4251 QD (Cohort 2) | Placebo QD (Cohort 2) | Total |
|---|---|---|---|---|---|
| United States | 10 | 5 | 10 | 11 | 36 |
| Composite score of eyelid discomfort, eyelid margin redness, and debris(units on a scale) | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) | NCX 4251 QD (Cohort 2) | Placebo QD (Cohort 2) | Total |
|---|---|---|---|---|---|
| Mean | 4.7 (4 to 6) | 5 (4 to 7) | 4.6 (4 to 6) | 4.5 (3 to 6) | 4.8 (3 to 7) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2019 to primary completion in Oct 2019, 7 months.
Results were first posted in Jan 2023, 3 years 2 months after primary completion. A results delay was requested in Nov 2020.
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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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Studies of the drug tested here: Fluticasone
Nicox Ophthalmics, Inc.