Miami, Florida 33136

  • Uveitis

Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT03584724


Primary Contact:

Principal Investigator
Pia Allegri
S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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