Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584724
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Bascom Palmer Eye Institute
Information provided by (Responsible Party):
Eye Pharma

Tracking Information
First Submitted Date  ICMJE April 26, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE December 19, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
The reduction of the mean number of relapses per patient between the year before treatment and the study period. [ Time Frame: 12 months ]
The primary statistical hypothesis to be assessed in this study is whether there is a difference in cell damage and inflammation reduction between the treatment group and placebo group. The cell damage and inflammation reduction will be measured by Laser Flare Meter.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03584724 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
The improvement of side effects due to HLA-B27-associated uveitis [ Time Frame: 12 months ]
The improvement of side effects due to HLA-B27-associated uveitis, such as intraocular pressure between NORFLO® ORO treatment group and control group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis
Official Title  ICMJE 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
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Uveitis
Intervention  ICMJE
  • Drug: Norflo Oro
    Norflo Oro is highly bioavailable curcumin complexed into phytosomes
    Other Name: Meriva
  • Drug: Placebo for Norflo Oro
    Placebo consist of look-alike single foil pouches without active ingredient of Norflo.
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Norflo Oro
    Box of 30 packets of Norflo Oro. The study subject will take the entire content of one packet with meal twice per day. The study subject will be evaluated in a total of three visits.
    Intervention: Drug: Norflo Oro
  • Placebo Comparator: Placebo for Norflo Oro
    Box of 30 packets of Placebo. The study subject will take the entire content of one packet with meal twice per day. The study subject will be evaluated in a total of three visits.
    Intervention: Drug: Placebo for Norflo Oro
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
5
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2018)
7
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584724
Other Study ID Numbers  ICMJE Norflo-Oro-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eye Pharma
Study Sponsor  ICMJE Eye Pharma
Collaborators  ICMJE Bascom Palmer Eye Institute
Investigators  ICMJE
Principal Investigator: Pia Allegri S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy
PRS Account Eye Pharma
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP