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

Early Phase 1CompletedNCT03584724

Eye Pharma49 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Uveitis

Interventions

Norflo OroDRUG

Norflo Oro is highly bioavailable curcumin complexed into phytosomes

Placebo for Norflo OroDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bascom Palmer Eye Institute

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 12 months

Secondary Outcomes

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)

Time frame: 12 months

Data from ClinicalTrials.gov

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