Trial · NCT03926026
Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
NCT03926026, Phase 2, Completed, Nicox Ophthalmics, Inc.; results first posted 2023-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis. Trials, record NCT03926026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03926026
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
- NCT number
- NCT03926026
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Nicox Ophthalmics, Inc.
- Conditions
- Blepharitis
- Interventions
- Fluticasone Propionate, Placebo
- First posted
- 2019-04-24
- Last updated
- 2023-06-18
- Results first posted
- 2023-01-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | 14 days | 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) |
| Secondary | COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | 14 days | 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) |
| Secondary | COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | 14 days | 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) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | 14 days | intent-to-treat population | units on a scale | MEAN |
| SECONDARY | COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | 14 days | intent-to-treat population | units on a scale | MEAN |
| SECONDARY | COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | 14 days | intent-to-treat population | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | NCX 4251 (Cohort 1 & 2 Combined) | -2.0 | Full Range -4 to 1 | units on a scale | |
| COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | Placebo (Cohort 1 & 2 Combined) | -1.2 | Full Range -2 to 1 | units on a scale | |
| COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | NCX 4251 BID (Cohort 2) | -1.7 | Full Range -3 to -1 | units on a scale | |
| COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | Placebo BID (Cohort 2) | -1.1 | Full Range -2 to 1 | units on a scale | |
| COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | NCX 4251 QD (Cohort 1) | -2.2 | Full Range -4 to 1 | units on a scale | |
| COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | Placebo QD (Cohort 1) | -1.2 | Full Range -2 to 0 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NCX 4251 QD -- Cohort 1 | 10 | |
| Overall Study | STARTED | Placebo QD -- Cohort 1 | 5 | |
| Overall Study | STARTED | NCX 4251 BID -- Cohort 2 | 10 | |
| Overall Study | STARTED | Placebo BID -- Cohort 2 | 11 | |
| Overall Study | COMPLETED | NCX 4251 QD -- Cohort 1 | 10 | |
| Overall Study | COMPLETED | Placebo QD -- Cohort 1 | 5 | |
| Overall Study | COMPLETED | NCX 4251 BID -- Cohort 2 | 10 | |
| Overall Study | COMPLETED | Placebo BID -- Cohort 2 | 11 | |
| Overall Study | NOT COMPLETED | NCX 4251 QD -- Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Placebo QD -- Cohort 1 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
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 | eyelid margin crusting | Eye disorders | NCX 4251 QD | 1 | 10 | 1 |
| other | eyelid margin crusting | Eye disorders | Placebo QD | 0 | 5 | 0 |
| other | eyelid margin crusting | Eye disorders | NCX 4251 BID | 0 | 10 | 0 |
| other | eyelid margin crusting | Eye disorders | Placebo BID | 0 | 11 | 0 |
| other | periorbital oedema | Eye disorders | NCX 4251 QD | 1 | 10 | 1 |
| other | periorbital oedema | Eye disorders | Placebo QD | 0 | 5 | 0 |
| other | periorbital oedema | Eye disorders | NCX 4251 BID | 0 | 10 | 0 |
| other | periorbital oedema | Eye disorders | Placebo BID | 0 | 11 | 0 |
| other | pruritus | Skin and subcutaneous tissue disorders | NCX 4251 QD | 1 | 10 | 1 |
| other | pruritus | Skin and subcutaneous tissue disorders | Placebo QD | 0 | 5 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NCX 4251 QD | 0 | 10 |
| Total, all-cause mortality | Placebo QD | 0 | 5 |
| Total, all-cause mortality | NCX 4251 BID | 0 | 10 |
| Total, all-cause mortality | Placebo BID | 0 | 11 |
| Total, other adverse events | NCX 4251 QD | 1 | 10 |
| Total, other adverse events | Placebo QD | 0 | 5 |
| Total, other adverse events | NCX 4251 BID | 5 | 10 |
| Total, other adverse events | Placebo BID | 0 | 11 |
| Total, serious adverse events | NCX 4251 QD | 0 | 10 |
| Total, serious adverse events | Placebo QD | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT03926026
GET https://conductscience.org/api/trials/v1/NCT03926026/events?page=2