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

Eye Pharma

Status and phase: Completed; Early Phase 1

Conditions: Uveitis

Treatments: Drug: Norflo Oro; Drug: Placebo for Norflo Oro

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03584724

Norflo-Oro-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

Norflo Oro

Experimental group

Description:

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.

Treatment:

Drug: Norflo Oro

Placebo for Norflo Oro

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo for Norflo Oro