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

Early Phase 1

Completed

• Conditions: Uveitis
• Interventions: Drug: Norflo Oro; Drug: Placebo for Norflo Oro

• Registration Number: NCT03584724
• Lead Sponsor: Eye Pharma

Brief 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.

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-12
• Study Start: 2018-12-19
• Primary Completion: 2020-08-20
• Study Completion: 2020-12-30
• Results First Submitted: 2021-11-04
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-25
• Last Update Submitted: 2022-03-25
• Results First Posted: 2022-03-28
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norflo Oro	Norflo Oro	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.
Placebo for Norflo Oro	Placebo for Norflo Oro	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.

Primary Outcome Measures

Name	Time	Method
Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline	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 Outcome Measures

Name	Time	Method
Changes in Side Effects Associated With HLA-B27 Uveitis	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)

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States