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Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis

NCT03584724 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-03-28

Study results available
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Summary

The purpose of this study is to explore the efficacy of Norflo Oro in the treatment of relapsing autoimmune uveitis (RAU), measured as a long term reduction of the frequency and the severity of relapses, in patients with HLA-B27 associated uveitis, under conditions of routine medical practice. The reduction of the mean number of relapses per patient between the year before study treatment and the study period will also be assessed.

Conditions

  • Uveitis

Interventions

DRUG

Norflo Oro

Norflo Oro is highly bioavailable curcumin complexed into phytosomes

DRUG

Placebo for Norflo Oro

Placebo consist of look-alike single foil pouches without active ingredient of Norflo.

Sponsors & Collaborators

  • Bascom Palmer Eye Institute

    collaborator OTHER

  • Eye Pharma

    lead INDUSTRY

Principal Investigators

  • Pia Allegri · S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2020-08-20
Completion
2020-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584724 on ClinicalTrials.gov