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CompletedNCT04675242MississippiUpdated Jun 18, 2023Results posted

Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis

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

Phase
Phase 2
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Blepharitis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • documented history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits
  • have a qualifying best-corrected visual acuity

Exclusion criteria

Exclusion Criteria:

  • abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery
  • IOP > 21 mmHg at Screening or Baseline/Day 1 Visits
  • use of steroids in the past 30 days or retinoids in the past 12 months
  • uncontrolled systemic disease
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
224 participants (actual)

Study arms

  • Experimental
    NCX 4251

    NCX 4251 Ophthalmic Suspension

    Drug: NCX 4251

  • Placebo comparator
    Placebo

    Vehicle of NCX 4251 Ophthalmic Suspension

    Drug: Placebo

Interventions

  • DrugNCX 4251

    NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily

  • DrugPlacebo

    Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

06

Results

Posted Dec 14, 2022

Participant flow

eyecare practictioners' practices

Participant flow — Overall Study
MilestoneNCX 4251Placebo
Started111113
Completed109112
Not completed21

Outcome measures

PrimaryPercentage 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
Reported as:
Count of units · study eyes
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15
study eyesNCX 4251Placebo
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 1542
Statistical analysis
  • NCX 4251 vs Placebo · Fisher Exact · p = 0.4434 · Mean difference (final values): 1.9 · 95% CI -11.5 to 15.3
SecondaryMean 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
Reported as:
Mean · units on a scale
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms
units on a scaleNCX 4251Placebo
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)
Statistical analysis
  • NCX 4251 vs Placebo · ANCOVA · p = 0.2105 · Mean difference (final values): -3.7 · 95% CI -9.5 to 2.1adjusted for baseline eye dryness VAS score
SecondaryMean 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
Reported as:
Mean · units on a scale
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)
units on a scaleNCX 4251Placebo
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)
Statistical analysis
  • NCX 4251 vs Placebo · ANCOVA · p = 0.5936 · Mean difference (final values): 0.0 · 95% CI -0.2 to 0.1adjusted for baseline eye dryness VAS score
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Adverse Events
ParticipantsNCX 4251Placebo
Treatment-emergent Adverse Events1217

Adverse events

Collected over 29 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NCX 42510/111 (0%)0/111 (0%)12/111 (10.8%)
Placebo0/113 (0%)0/113 (0%)20/113 (17.7%)
Most frequent other events
Showing 10 of 22
Most frequent other events
EventNCX 4251Placebo
Instillation site painGeneral disorders1/1115/113
Visual acuity reducedEye disorders1/1112/113
Eye pruritusEye disorders1/1111/113
Vitreous detachmentEye disorders1/1111/113
Eyelids pruritusEye disorders1/1110/113
PapillomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1110/113
Conjunctival hyperaemiaEye disorders1/1110/113
Procedural painInjury, poisoning and procedural complications1/1110/113
SplinterInjury, poisoning and procedural complications1/1110/113
Back painMusculoskeletal and connective tissue disorders1/1111/113

Baseline characteristics

Study Eye

Age, Categorical
Age, Categorical(Participants)NCX 4251PlaceboTotal
<=18 years000
Between 18 and 65 years6350113
>=65 years4863111
Age, Continuous
Age, Continuous(years)NCX 4251PlaceboTotal
Mean61.4 ± 13.7563.2 ± 14.3162.3 ± 14.03
Sex: Female, Male
Sex: Female, Male(Participants)NCX 4251PlaceboTotal
Female7567142
Male364682
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NCX 4251PlaceboTotal
Hispanic or Latino5813
Not Hispanic or Latino106105211
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NCX 4251PlaceboTotal
American Indian or Alaska Native000
Asian123
Native Hawaiian or Other Pacific Islander000
Black or African American262147
White8487171
More than one race033
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)NCX 4251PlaceboTotal
United States111113224
Composite Score of Eyelid Margin Redness + Eyelid Debris + Eyelid Discomfort in the study eye
Composite Score of Eyelid Margin Redness + Eyelid Debris + Eyelid Discomfort in the study eye(units on a scale for study eyes)NCX 4251PlaceboTotal
Mean4.6 (3 to 8)4.7 (3 to 7)4.7 (3 to 7)
Eye Dryness
Eye Dryness(units on a scale for study eyes)NCX 4251PlaceboTotal
Mean59.1 (4 to 99)57.5 (0 to 99)58.3 (0 to 99)

1 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Eye Research Foundation
    Newport Beach, California 92663, United States
08

References and documents

Study documents

  • Study protocol · Mar 24, 2021
  • Statistical analysis plan · Aug 4, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT04675242
Lead sponsor
Nicox Ophthalmics, Inc.
Responsible party
Sponsor
First posted
Dec 19, 2020
Start date
Dec 14, 2020
Primary completion
Jun 16, 2021
Completion
Jun 30, 2021
Results posted
Dec 14, 2022
Last update
Jun 18, 2023

Study contacts

Nicox Ophthalmics
study director · Nicox Ophthalmics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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