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Completed

NCT Number: NCT03584724

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

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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Key information

Conditions

Uveitis Disease Attributes Eye Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Norflo Oro

Drug

Norflo Oro is highly bioavailable curcumin complexed into phytosomes

Other names: Meriva

Placebo for Norflo Oro

Drug

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

Other names: Placebo

Primary outcomes

  1. Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline

    Time frame: Baseline and 12 months

    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 outcomes

  1. Changes in Side Effects Associated With HLA-B27 Uveitis

    Time frame: 12 months

    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)

Sponsors and collaborators

Lead sponsor

Eye Pharma

Industry

Collaborators

  • Bascom Palmer Eye Institute

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2018
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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