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

Primary Purpose

Uveitis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Norflo Oro
Placebo for Norflo Oro
Sponsored by
Eye Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring HLA-B27, relapses, curcumin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bascom Palmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Norflo Oro

Placebo for Norflo Oro

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
April 26, 2018
Last Updated
March 25, 2022
Sponsor
Eye Pharma
Collaborators
Bascom Palmer Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03584724
Brief Title
Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye Pharma
Collaborators
Bascom Palmer Eye Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
HLA-B27, relapses, curcumin

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Up to 60 eligible patients will be randomly assigned to NORFLO® ORO or placebo treatment groups in a 1:1 ratio using a stratified randomization blocks scheme.
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norflo Oro
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo for Norflo Oro
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Norflo Oro
Other Intervention Name(s)
Meriva
Intervention Description
Norflo Oro is highly bioavailable curcumin complexed into phytosomes
Intervention Type
Drug
Intervention Name(s)
Placebo for Norflo Oro
Other Intervention Name(s)
Placebo
Intervention Description
Placebo consist of look-alike single foil pouches without active ingredient of Norflo.
Primary Outcome Measure Information:
Title
Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline
Description
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.
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Changes in Side Effects Associated With HLA-B27 Uveitis
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Allegri
Organizational Affiliation
S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21060672
Citation
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.
Results Reference
background
PubMed Identifier
23241930
Citation
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.
Results Reference
background
PubMed Identifier
23723686
Citation
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.
Results Reference
background
PubMed Identifier
35353651
Citation
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. 2023 Apr;31(3):526-535. doi: 10.1080/09273948.2022.2039210. Epub 2022 Mar 30.
Results Reference
derived

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

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