Trial Outcomes & Findings for Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis (NCT NCT03584724)

Last Updated: 2022-03-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

49 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2022-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	25	24
Overall Study COMPLETED	18	23
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Norflo Oro n=25 Participants 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	Placebo for Norflo Oro n=24 Participants 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.	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	46.40 years STANDARD_DEVIATION 13.21 • n=5 Participants	50.88 years STANDARD_DEVIATION 14.90 • n=7 Participants	48.59 years STANDARD_DEVIATION 14.10 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Italy	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants
Region of Enrollment Turkey	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Relapses Per Patient	1.95 Relapses STANDARD_DEVIATION 0.94 • n=5 Participants	1.50 Relapses STANDARD_DEVIATION 0.83 • n=7 Participants	1.71 Relapses STANDARD_DEVIATION 0.94 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: 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).

Outcome measures

Outcome measures
Measure	Norflo Oro n=20 Participants 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	Placebo for Norflo Oro n=24 Participants 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.
Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline	0.35 Relapses Per Patient Standard Deviation 0.75	0.58 Relapses Per Patient Standard Deviation 0.88

SECONDARY outcome

Timeframe: 12 months

Population: Only participants that completed the study were included in the 12-month evaluation

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)

Outcome measures

Outcome measures
Measure	Norflo Oro n=20 Participants 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	Placebo for Norflo Oro n=24 Participants 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.
Changes in Side Effects Associated With HLA-B27 Uveitis IOP change (right eye)	0.44 mmHg Standard Deviation 1.85	0.22 mmHg Standard Deviation 3.01
Changes in Side Effects Associated With HLA-B27 Uveitis IOP change (left eye)	-0.06 mmHg Standard Deviation 1.70	-0.09 mmHg Standard Deviation 2.37

Adverse Events

Norflo Oro

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo for Norflo Oro

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Norflo Oro n=20 participants at risk 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	Placebo for Norflo Oro n=24 participants at risk 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.
Musculoskeletal and connective tissue disorders wrist fracture	5.0% 1/20 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/24 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Injury, poisoning and procedural complications drink poisoning	5.0% 1/20 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/24 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Musculoskeletal and connective tissue disorders Fracture of the foot	5.0% 1/20 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/24 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.

Other adverse events

Other adverse events
Measure	Norflo Oro n=20 participants at risk 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	Placebo for Norflo Oro n=24 participants at risk 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.
Eye disorders eye disorders	20.0% 4/20 • Number of events 16 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	29.2% 7/24 • Number of events 13 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Gastrointestinal disorders gastrointestinal disorders	60.0% 12/20 • Number of events 34 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	41.7% 10/24 • Number of events 18 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
General disorders General disorders and administration site conditions	20.0% 4/20 • Number of events 4 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	12.5% 3/24 • Number of events 4 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Infections and infestations Infections and infestations	40.0% 8/20 • Number of events 16 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	33.3% 8/24 • Number of events 14 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	20.0% 4/20 • Number of events 4 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	8.3% 2/24 • Number of events 3 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Investigations investigations	0.00% 0/20 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	4.2% 1/24 • Number of events 1 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Metabolism and nutrition disorders metabolism and nutrition disorders	5.0% 1/20 • Number of events 1 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/24 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Musculoskeletal and connective tissue disorders Muskoloskeletal and connective tissue disorders	10.0% 2/20 • Number of events 5 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	20.8% 5/24 • Number of events 9 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Nervous system disorders nervous system disorders	25.0% 5/20 • Number of events 22 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	29.2% 7/24 • Number of events 10 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Renal and urinary disorders renal and urinary disorders	10.0% 2/20 • Number of events 2 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/24 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Respiratory, thoracic and mediastinal disorders respiratory, thoracic and mediastinal disorders	15.0% 3/20 • Number of events 3 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	8.3% 2/24 • Number of events 2 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders skin and subcutaneous tissue disorders	5.0% 1/20 • Number of events 1 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/24 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Vascular disorders vascular disorders	10.0% 2/20 • Number of events 2 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	12.5% 3/24 • Number of events 3 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Ear and labyrinth disorders ear and labyrinth disorders	0.00% 0/20 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	4.2% 1/24 • Number of events 4 • 1 year Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.

Additional Information

Elena Meloni

Eye Pharma

Phone: 7862187339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place