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| Name | Class |
|---|---|
| Bascom Palmer Eye Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norflo Oro | Experimental | The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. |
|
| Placebo for Norflo Oro | Placebo Comparator | The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norflo Oro | Drug | Norflo Oro is highly bioavailable curcumin complexed into phytosomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pia Allegri | S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21060672 | Background | 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. | |
| 23241930 | Background | 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(R), a lecithinized curcumin delivery system, in diabetic microangiopathy and retinopathy. Panminerva Med. 2012 Dec;54(1 Suppl 4):11-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Norflo Oro | The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. Norflo Oro: Norflo Oro is highly bioavailable curcumin complexed into phytosomes |
| FG001 | Placebo for Norflo Oro | The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Norflo Oro | The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. Norflo Oro: Norflo Oro is highly bioavailable curcumin complexed into phytosomes |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only patients that completed the 12 month study were included in the analysis of the mean number of relapses per patient during the study duration (12 months). | Posted | Mean | Standard Deviation | Relapses Per Patient | Baseline and 12 months |
|
1 year
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Norflo Oro | The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. Norflo Oro: Norflo Oro is highly bioavailable curcumin complexed into phytosomes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wrist fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eye disorders | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elena Meloni | Eye Pharma | 7862187339 | elena.meloni@eyepharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2019 | Nov 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2020 | Nov 4, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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Up to 60 eligible patients will be randomly assigned to NORFLO® ORO or placebo treatment groups in a 1:1 ratio using a stratified randomization blocks scheme.
| Placebo for Norflo Oro | Drug | Placebo consist of look-alike single foil pouches without active ingredient of Norflo. |
|
|
| 23723686 | Background | 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. |
| 35353651 | Derived | Allegri P, Cimino L, Davis JL, Tugal-Tutkun I; Norflo Oro study group. Assessment of the Anti-inflammatory Effects of NORFLO(R) ORO in Acute Relapses of HLA-B27-associated Autoimmune Uveitis: A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study. Ocul Immunol Inflamm. 2023 Apr;31(3):526-535. doi: 10.1080/09273948.2022.2039210. Epub 2022 Mar 30. |
| Placebo for Norflo Oro |
The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Relapses Per Patient | Number of relapses as episodes of uveitis recurrence | Mean | Standard Deviation | Relapses |
|
| OG001 | Placebo for Norflo Oro | The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo. |
|
|
| 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) | Only participants that completed the study were included in the 12-month evaluation | Posted | Mean | Standard Deviation | mmHg | 12 months |
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| 0 |
| 20 |
| 3 |
| 20 |
| 20 |
| 20 |
| EG001 | Placebo for Norflo Oro | The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits. Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo. | 0 | 24 | 0 | 24 | 19 | 24 |
| drink poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fracture of the foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| investigations | Investigations | Systematic Assessment |
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| metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Muskoloskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| nervous system disorders | Nervous system disorders | Systematic Assessment |
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| renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| vascular disorders | Vascular disorders | Systematic Assessment |
|
| ear and labyrinth disorders | Ear and labyrinth disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |