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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis

Clinicaltrials.gov identifier NCT03926026

Recruitment Status Completed

First Posted April 24, 2019

Last update posted January 13, 2020

Study Description

Brief summary:

This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2 study evaluating the safety and tolerability of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD and BID for the treatment of acute exacerbations of blepharitis. The study will be performed in two sequential dose escalating cohorts. The study is designed to select the dose(s) of NCX 4251 to advance into the next stage of development, and to assess the safety and tolerability of NCX 4251 Ophthalmic Suspension.

  • Condition or Disease:Blepharitis
  • Intervention/Treatment: Drug: Fluticasone Propionate
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 44 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation, Phase 2 Study Evaluating the Safety and Tolerability of NCX 4251 (Fluticasone Propionate Nanocrystal) Ophthalmic Suspension, 0.1% QD and BID for the Treatment of Acute Exacerbations of Blepharitis
  • Actual Study Start Date: March 2019
  • Actual Primary Completion Date: October 2019
  • Actual Study Completion Date: October 2019
Arms and interventions
Arm Intervention/treatment
Experimental: NCX 4251 BID
NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Drug: Fluticasone Propionate
NCX 4251 Ophthalmic Suspension, 0.1%
Experimental: NCX 4251 QD
NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Drug: Fluticasone Propionate
NCX 4251 Ophthalmic Suspension, 0.1%
Placebo Comparator: Placebo BID
Placebo twice daily for 14 days
Drug: Placebo
NCX 4251 Ophthalmic Suspension, 0%
Placebo Comparator: Placebo QD
Placebo once daily for 14 days
Drug: Placebo
NCX 4251 Ophthalmic Suspension, 0%
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of treatment-emergent ocular and systemic adverse events (safety and tolerability) [ Time Frame: 28 days ]
    Incidence of treatment-emergent ocular and systemic adverse events (safety and tolerability)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 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
Contacts
Locations

United States, Texas
Texan Eye
Austin

Sponsors and Collaborators

Nicox Ophthalmics, Inc.

Investigators

Study Director: Tomas Navratil, PhD Nicox Ophthalmics, Inc.

More Information
  • Responsible Party: Nicox Ophthalmics, Inc.
  • ClinicalTrials.gov Identifier: NCT03926026 History of Changes
  • Other Study ID Numbers: NCX-4251-01
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: January 13, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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