BlepharitisPhase 2MississippiNCT04675242

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

A Phase 2 study testing NCX 4251 in people with Blepharitis, run by Nicox Ophthalmics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Blepharitis
What is being tested?: NCX 4251
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 224 participants
Where: 1 siteUnited States
Study dates: 14 Dec 2020to 30 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Eye Research Foundation
Newport Beach, California, 92663

Other trials in United States

About this study

Official title: Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension, 0.1% QD for the Treatment of Acute Exacerbations of Blepharitis (Mississippi)

Conditions: Blepharitis
Being tested: NCX 4251, Placebo
Medical subject headings: Blepharitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NCX 4251Drug
NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
PlaceboDrug
Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily

Study groups in NCT04675242
Study group	Role	What they receive
NCX 4251	Experimental	NCX 4251 Ophthalmic Suspension Receives: Drug: NCX 4251
Placebo	Placebo comparator	Vehicle of NCX 4251 Ophthalmic Suspension Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 15 Visit

Secondary outcomes (3)

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
Measured: 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
Measured: 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)
Measured: 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 202030 Jun 2021

First posted19 Dec 2020
Study start14 Dec 2020
Primary completion16 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BlepharitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04675242
Sponsor's protocol ID: NCX-4251-02
Acronym: Mississippi
Status last verified: Jun 2023
First submitted: 15 Dec 2020
Last updated: 18 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
RecruitingObservational study
Ocular Dysbiosis in Eyelid Disease
Anterior Blepharitis
Not yet recruitingPhase 4
Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study
Anterior Blepharitis
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingPhase 2
Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Demodex Blepharitis

All Blepharitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension, 0.1% QD for the Treatment of Acute Exacerbations of Blepharitis (Mississippi)
ClinicalTrials.gov ID: NCT04675242
Acronym / sponsor ID: Mississippi / NCX-4251-02
Conditions: Blepharitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Nicox Ophthalmics, Inc.Industry (pharma, biotech, devices)
Study start: 14 Dec 2020 (actual)
Primary completion: 16 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 19 Dec 2020 (actual)
Results: Posted 14 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
NCX 4251	Experimental	Drug: NCX 4251NCX 4251 Ophthalmic Suspension
Placebo	Placebo comparator	Drug: PlaceboVehicle of NCX 4251 Ophthalmic Suspension

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NCX 4251NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily	Drug	NCX 4251
PlaceboVehicle of NCX 4251 Ophthalmic Suspension dosed once daily	Drug	Placebo

Primary outcome

Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15
Time frame: 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

3 secondary outcomes

Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms
Time frame: Day 15 Visit
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)
Time frame: Day 15 Visit
Treatment-emergent Adverse Events
Time frame: 29 days

Results and safety

Results posted to the registry on 14 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NCX 4251	111	109
Placebo	113	112

Primary outcome: Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15

Time frame: Day 15 Visit. Count of units. Unit: study eyes

Measure	NCX 4251 n = 109	Placebo n = 111
Value	4	2

NCX 4251 vs Placebo: Mean Difference (Final Values): 1.9 (95% CI -11.5 to 15.3), p = 0.4434, Fisher Exact

Population analysed: Intent to treat (for study eyes with data for all 3 scales at the Baseline and Day 15 Visit)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 29 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NCX 4251	0 of 111 (0%)	12 of 111 (10.8%)	0 of 111
Placebo	0 of 113 (0%)	20 of 113 (17.7%)	0 of 113

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Blepharitis

Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
RecruitingObservational study
Ocular Dysbiosis in Eyelid Disease
Anterior Blepharitis
Not yet recruitingPhase 4
Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study
Anterior Blepharitis
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingPhase 2
Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Demodex Blepharitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicox Ophthalmics study director

Nicox Ophthalmics, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NCX 4251 in people with Blepharitis, run by Nicox Ophthalmics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 (time frame: Day 15 Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04675242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.