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
Verified date | March 2022 |
Source | Eye Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Bascom Palmer Eye Institute | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Eye Pharma | Bascom Palmer Eye Institute |
United States,
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
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 |
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