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

Uveitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584724
• Other study ID #: Norflo-Oro-16
• Status: Completed
• Phase: Early Phase 1
• Start date: December 19, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2022
• Source: Eye Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 30, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Uveitis

Intervention

Drug:
• Norflo Oro
Norflo Oro is highly bioavailable curcumin complexed into phytosomes
• Placebo for Norflo Oro
Placebo consist of look-alike single foil pouches without active ingredient of Norflo.

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eye Pharma	Bascom Palmer Eye Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

Allegri P, Mastromarino A, Neri P. Management of chronic anterior uveitis relapses: efficacy of oral phospholipidic curcumin treatment. Long-term follow-up. Clin Ophthalmol. 2010 Oct 21;4:1201-6. doi: 10.2147/OPTH.S13271. — View Citation

Mazzolani F, Togni S. Oral administration of a curcumin-phospholipid delivery system for the treatment of central serous chorioretinopathy: a 12-month follow-up study. Clin Ophthalmol. 2013;7:939-45. doi: 10.2147/OPTH.S45820. Epub 2013 May 22. — View Citation

Steigerwalt R, Nebbioso M, Appendino G, Belcaro G, Ciammaichella G, Cornelli U, Luzzi R, Togni S, Dugall M, Cesarone MR, Ippolito E, Errichi BM, Ledda A, Hosoi M, Corsi M. Meriva®, a lecithinized curcumin delivery system, in diabetic microangiopathy and retinopathy. Panminerva Med. 2012 Dec;54(1 Suppl 4):11-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline	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.	Baseline and 12 months
Secondary	Changes in Side Effects Associated With HLA-B27 Uveitis	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)	12 months