Early Phase 1 N=49 Randomized Quadruple-blind Treatment

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

Uveitis

Bottom Line

View on ClinicalTrials.gov: NCT03584724 ↗

Enrolled (actual)

Serious AEs

6.8%

Results posted

Mar 2022

Primary outcome: Primary: Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline — 0.35; 0.58 Relapses Per Patient

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Norflo Oro (Drug); Placebo for Norflo Oro (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eye Pharma
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline	0.35; 0.58	—
SECONDARY Changes in Side Effects Associated With HLA-B27 Uveitis	0.44; 0.22; -0.06; -0.09	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03584724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.