NCT03584724

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Eye Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	Norflo Oro	Norflo Oro is highly bioavailable curcumin complexed into phytosomes
DRUG	Placebo for Norflo Oro	Placebo consist of look-alike single foil pouches without active ingredient of Norflo.

Timeline

• Start date: 2018-12-19
• Primary completion: 2020-08-20
• Completion: 2020-12-30
• First posted: 2018-07-12
• Last updated: 2022-03-28
• Results posted: 2022-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study