CompletedEarly Phase 1

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

United States49 participantsStarted 2018-12-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline

Timeframe: Baseline and 12 months

Trial details

NCT IDNCT03584724

SponsorEye Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-20

Results submitted2021-11-04

View on ClinicalTrials.gov More Uveitis trials