- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04675242
Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis (Mississippi)
June 15, 2023 updated by: Nicox Ophthalmics, Inc.
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)
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
224
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Newport Beach, California, United States, 92663
- Eye Research Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NCX 4251
NCX 4251 Ophthalmic Suspension
|
NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
|
Placebo Comparator: Placebo
Vehicle of NCX 4251 Ophthalmic Suspension
|
Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 15 Visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms
Time Frame: 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
|
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
|
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
|
Day 15 Visit
|
Treatment-emergent Adverse Events
Time Frame: 29 days
|
Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)
|
29 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nicox Ophthalmics, Nicox Ophthalmics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2020
Primary Completion (Actual)
June 16, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
December 15, 2020
First Submitted That Met QC Criteria
December 15, 2020
First Posted (Actual)
December 19, 2020
Study Record Updates
Last Update Posted (Estimated)
June 19, 2023
Last Update Submitted That Met QC Criteria
June 15, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCX-4251-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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