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Trial record 4 of 5 for:    "Blepharitis" | "Anti-Allergic Agents"

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

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ClinicalTrials.gov Identifier: NCT03926026
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Nicox Ophthalmics, Inc.

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 Intervention/treatment Phase
Blepharitis Drug: Fluticasone Propionate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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)
Masking Description: double-masked
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 18, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NCX 4251 QD
NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Drug: Fluticasone Propionate
NCX 4251 Ophthalmic Suspension, 0.1%
Other Name: NCX 4251

Placebo Comparator: Placebo QD
Placebo once daily for 14 days
Drug: Placebo
NCX 4251 Ophthalmic Suspension, 0%

Experimental: NCX 4251 BID
NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Drug: Fluticasone Propionate
NCX 4251 Ophthalmic Suspension, 0.1%
Other Name: NCX 4251

Placebo Comparator: Placebo BID
Placebo twice daily for 14 days
Drug: Placebo
NCX 4251 Ophthalmic Suspension, 0%




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926026


Contacts
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Contact: Nicox Ophthalmics, Inc. 919-314-8374 NCX4251@nicox.com

Locations
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United States, Texas
Texan Eye Recruiting
Austin, Texas, United States, 78731
Contact: Robert Stapper         
Sponsors and Collaborators
Nicox Ophthalmics, Inc.
Investigators
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Study Director: Tomas Navratil, PhD Nicox Ophthalmics, Inc.

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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: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blepharitis
Anti-Allergic Agents
Eyelid Diseases
Eye Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents