Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | December 19, 2018 |
| End Date: | December 2020 |
| Contact: | Elena Meloni, MS |
| Email: | elena.meloni@eyepharma.com |
| Phone: | 786-218-7339 |
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
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.
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.
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.
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.
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.
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