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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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ClinicalTrials.gov Identifier: NCT03584724
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Bascom Palmer Eye Institute
Information provided by (Responsible Party):
Eye Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uveitis Drug: Norflo Oro Drug: Placebo for Norflo Oro Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Norflo Oro
Box of 30 packets of Norflo Oro. The study subject will take the entire content of one packet with meal twice per day. 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 Name: Meriva
Placebo Comparator: Placebo for Norflo Oro
Box of 30 packets of Placebo. The study subject will take the entire content of one packet with meal twice per day. 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 Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. The reduction of the mean number of relapses per patient between the year before treatment and the study period. [ Time Frame: 12 months ]
    The primary statistical hypothesis to be assessed in this study is whether there is a difference in cell damage and inflammation reduction between the treatment group and placebo group. The cell damage and inflammation reduction will be measured by Laser Flare Meter.


Secondary Outcome Measures :
  1. The improvement of side effects due to HLA-B27-associated uveitis [ Time Frame: 12 months ]
    The improvement of side effects due to HLA-B27-associated uveitis, such as intraocular pressure between NORFLO® ORO treatment group and control group.


Eligibility Criteria
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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:

  • 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.
Contacts and Locations
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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): NCT03584724


Locations
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United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
Eye Pharma
Bascom Palmer Eye Institute
Investigators
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Principal Investigator: Pia Allegri S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Eye Pharma
ClinicalTrials.gov Identifier: NCT03584724     History of Changes
Other Study ID Numbers: Norflo-Oro-16
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 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

Keywords provided by Eye Pharma:
HLA-B27
relapses
curcumin

Additional relevant MeSH terms:
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Uveitis
Recurrence
Disease Attributes
Pathologic Processes
 Uveal Diseases
Eye Diseases
Anti-Inflammatory Agents