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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03926026
Other study ID # NCX-4251-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 18, 2019
Est. completion date October 21, 2019

Study information

Verified date June 2023
Source Nicox Ophthalmics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date October 21, 2019
Est. primary completion date October 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fluticasone Propionate
NCX 4251 Ophthalmic Suspension, 0.1%
Placebo
NCX 4251 Ophthalmic Suspension, 0%

Locations

Country Name City State
United States Texan Eye Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
Nicox Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis COHORT 1 and 2 COMBINED: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) 14 days
Secondary COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis COHORT 2: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) 14 days
Secondary COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis COHORT 1: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) 14 days
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