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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Norflo Oro

Intervention Type DRUG

Norflo Oro is highly bioavailable curcumin complexed into phytosomes

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.

Group Type PLACEBO_COMPARATOR

Placebo for Norflo Oro

Intervention Type DRUG

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

Interventions

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Norflo Oro

Norflo Oro is highly bioavailable curcumin complexed into phytosomes

Intervention Type DRUG

Placebo for Norflo Oro

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

Intervention Type DRUG

Other Intervention Names

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Meriva Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No