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

Sponsor
Nicox Ophthalmics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04675242
Collaborator
(none)
320
Enrollment
1
Location
2
Arms
6.5
Actual Duration (Months)
49.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NCX 4251
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
double-masked
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Dec 14, 2020
Actual Primary Completion Date :
Jun 16, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: NCX 4251

NCX 4251 Ophthalmic Suspension

Drug: NCX 4251
NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
Placebo Comparator: Placebo

Vehicle of NCX 4251 Ophthalmic Suspension

Drug: Placebo
Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects with Complete Cure (Score 0) of Blepharitis Signs and Symptoms [Day 15 Visit]

    Proportion of subjects 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 Outcome Measures

  1. 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)

  2. Eye Dryness Sign [Day 15 Visit]

    Mean change from baseline in fluorescein staining of the inferior cornea

  3. Treatment-emergent adverse events [28 days]

    Incidence of treatment-emergent adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Research Foundation Newport Beach California United States 92663

Sponsors and Collaborators

  • Nicox Ophthalmics, Inc.

Investigators

  • Study Director: Jose L Boyer, PhD, Nicox Ophthalmics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nicox Ophthalmics, Inc.
ClinicalTrials.gov Identifier:
NCT04675242
Other Study ID Numbers:
  • NCX-4251-02
First Posted:
Dec 19, 2020
Last Update Posted:
Jul 2, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Blepharitis

Study Results

No Results Posted as of Jul 2, 2021