Trial · NCT04675242

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

NCT04675242, Phase 2, Completed, Nicox Ophthalmics, Inc.; results first posted 2022-12-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis. Trials, record NCT04675242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04675242

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis
NCT number: NCT04675242
Status: Completed
Phases: Phase 2
Enrollment: 224 participants, actual
Lead sponsor: Nicox Ophthalmics, Inc.
Conditions: Blepharitis
Interventions: NCX 4251, Placebo
First posted: 2020-12-19
Last updated: 2023-06-18
Results first posted: 2022-12-14

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15	Day 15 Visit	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
Secondary	Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms	Day 15 Visit	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
Secondary	Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)	Day 15 Visit	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
Secondary	Treatment-emergent Adverse Events	29 days	Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15	Day 15 Visit	Intent to treat (for study eyes with data for all 3 scales at the Baseline and Day 15 Visit)	study eyes	COUNT_OF_UNITS
SECONDARY	Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms	Day 15 Visit	intent to treat (in study eyes with data at Baseline and Day 15 Visit)	units on a scale	MEAN
SECONDARY	Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)	Day 15 Visit	intent to treat (for study eyes with data at Baseline and Day 15)	units on a scale	MEAN
SECONDARY	Treatment-emergent Adverse Events	29 days	Safety population (all randomized subjects who received at least one dose of the intervention)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15	NCX 4251	4		study eyes
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15	Placebo	2		study eyes
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms	NCX 4251	-16.4	95% Confidence Interval -20.7 to -12.0	units on a scale
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms	Placebo	-12.5	95% Confidence Interval -16.5 to -8.5	units on a scale
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)	NCX 4251	-0.18	95% Confidence Interval -0.34 to -0.02	units on a scale
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)	Placebo	-0.13	95% Confidence Interval -0.26 to 0.01	units on a scale
Treatment-emergent Adverse Events	NCX 4251	12		Participants
Treatment-emergent Adverse Events	Placebo	17		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	NCX 4251	111	111
Overall Study	STARTED	Placebo	113	113
Overall Study	COMPLETED	NCX 4251	109	109
Overall Study	COMPLETED	Placebo	112	112
Overall Study	NOT COMPLETED	NCX 4251	2	2
Overall Study	NOT COMPLETED	Placebo	1	1

Source ClinicalTrials.gov

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Visual acuity reduced	Eye disorders	NCX 4251	1	111	1
other	Visual acuity reduced	Eye disorders	Placebo	2	113	2
other	Eye pruritus	Eye disorders	NCX 4251	1	111	1
other	Eye pruritus	Eye disorders	Placebo	1	113	1
other	Vitreous detachment	Eye disorders	NCX 4251	1	111	1
other	Vitreous detachment	Eye disorders	Placebo	1	113	1
other	Conjunctival haemorrhage	Eye disorders	NCX 4251	0	111	0
other	Conjunctival haemorrhage	Eye disorders	Placebo	1	113	1
other	Eyelid irritation	Eye disorders	NCX 4251	0	111	0
other	Eyelid irritation	Eye disorders	Placebo	1	113	1

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NCX 4251	0	111
Total, all-cause mortality	Placebo	0	113
Total, other adverse events	NCX 4251	12	111
Total, other adverse events	Placebo	20	113
Total, serious adverse events	NCX 4251	0	111
Total, serious adverse events	Placebo	0	113

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
NCX 4251 vs Placebo: Treatment-emergent Adverse Events	Trial comparisons
NCX 4251 vs Placebo: deaths from any cause	Trial comparisons
NCX 4251 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04675242

GET https://conductscience.org/api/trials/v1/NCT04675242/events?page=2

API reference For AI assistants