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

Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis: a Multicenter Randomized, Placebo Controlled, Double-blind Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Uveitis
• Intervention / Treatment: Drug: Norflo Oro; Drug: Placebo for Norflo Oro

Detailed Description

The secondary objective of this study will be: (i) evaluation of the improvement of side effects due to HLA-B27 associated uveitis such as intraocular pressure (IOP), cystoid macular edema, keratophaty and synechia (ii) evaluation of the improvement in uveitis-related symptoms: BCVA and symptoms measured by VAS, like ocular pain, photophobia, floaters and blurred vision; (iii) evaluation of cell damage and inflammation reduction in patients with HLA-B27 associated uveitis; (iv) evaluation of the patients' attitude towards the study treatment and also the evaluation of the safety profile of the study product.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of HLA-B27 positive related uveitis in non- acute phase
• At least one autoimmune uveitis relapse

Exclusion Criteria:

• Use of supplements (nutraceuticals) or systemic therapy for uveitis with anti-inflammatory immunosuppressive or biological drugs within last 30 days
• Anticipated need for systemic anti-inflammatory treatment during the study
• Use of intravitreal peribulbar, sub-tenon, periocular injection in the previous 6 months
• Long-term treatment with a systemic anti-inflammatory, immune suppressant drugs
• Woman taking hormonal contraceptives, pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norflo Oro; The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.	Drug: Norflo Oro; Norflo Oro is highly bioavailable curcumin complexed into phytosomes; Other Names: Meriva
Placebo Comparator: Placebo for Norflo Oro; The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.	Drug: Placebo for Norflo Oro; Placebo consist of look-alike single foil pouches without active ingredient of Norflo.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline	The mean number of uveitis relapses per patient in the 12 months of study duration (12 months) will be compared to the average number of uveitis relapses per patient in the 12 months before (baseline) for the Norflo Oro group and for the Placebo group.	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Side Effects Associated With HLA-B27 Uveitis	The changes in side effects associated with HLA-B27 uveitis, such as intraocular pressure (IOP) in the NORFLO® ORO treatment group and control group at the end of the study (12 month) compared to the 12 months before the study started (baseline)	12 months

Collaborators and Investigators

• Sponsor: Eye Pharma
• Collaborators: Bascom Palmer Eye Institute
• Investigators: Principal Investigator: Pia Allegri, S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy

Publications and helpful links

General Publications

• Allegri P, Mastromarino A, Neri P. Management of chronic anterior uveitis relapses: efficacy of oral phospholipidic curcumin treatment. Long-term follow-up. Clin Ophthalmol. 2010 Oct 21;4:1201-6. doi: 10.2147/OPTH.S13271.
• Steigerwalt R, Nebbioso M, Appendino G, Belcaro G, Ciammaichella G, Cornelli U, Luzzi R, Togni S, Dugall M, Cesarone MR, Ippolito E, Errichi BM, Ledda A, Hosoi M, Corsi M. Meriva(R), a lecithinized curcumin delivery system, in diabetic microangiopathy and retinopathy. Panminerva Med. 2012 Dec;54(1 Suppl 4):11-6.
• Mazzolani F, Togni S. Oral administration of a curcumin-phospholipid delivery system for the treatment of central serous chorioretinopathy: a 12-month follow-up study. Clin Ophthalmol. 2013;7:939-45. doi: 10.2147/OPTH.S45820. Epub 2013 May 22.
• Allegri P, Cimino L, Davis JL, Tugal-Tutkun I; Norflo Oro study group. Assessment of the Anti-inflammatory Effects of NORFLO(R) ORO in Acute Relapses of HLA-B27-associated Autoimmune Uveitis: A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study. Ocul Immunol Inflamm. 2022 Mar 30:1-10. doi: 10.1080/09273948.2022.2039210. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: curcumin; HLA-B27; relapses
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Uveal Diseases; Recurrence; Uveitis
• Other Study ID Numbers: Norflo-Oro-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No