Trial · NCT03584724
Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis
NCT03584724, Early phase 1, Completed, Eye Pharma; results first posted 2022-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis. Trials, record NCT03584724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03584724
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis
- NCT number
- NCT03584724
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 49 participants, actual
- Lead sponsor
- Eye Pharma
- Conditions
- Uveitis
- Interventions
- Norflo Oro, Placebo for Norflo Oro
- First posted
- 2018-07-12
- Last updated
- 2022-03-28
- Results first posted
- 2022-03-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline | Baseline and 12 months | 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. |
| Secondary | Changes in Side Effects Associated With HLA-B27 Uveitis | 12 months | 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) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline | Baseline and 12 months | 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). | Relapses Per Patient | MEAN |
| SECONDARY | Changes in Side Effects Associated With HLA-B27 Uveitis | 12 months | Only participants that completed the study were included in the 12-month evaluation | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline | Norflo Oro | 0.35 | Standard Deviation 0.75 | Relapses Per Patient | |
| Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline | Placebo for Norflo Oro | 0.58 | Standard Deviation 0.88 | Relapses Per Patient | |
| Changes in Side Effects Associated With HLA-B27 Uveitis | Norflo Oro | IOP change (right eye) | 0.44 | Standard Deviation 1.85 | mmHg |
| Changes in Side Effects Associated With HLA-B27 Uveitis | Placebo for Norflo Oro | IOP change (right eye) | 0.22 | Standard Deviation 3.01 | mmHg |
| Changes in Side Effects Associated With HLA-B27 Uveitis | Norflo Oro | IOP change (left eye) | -0.06 | Standard Deviation 1.70 | mmHg |
| Changes in Side Effects Associated With HLA-B27 Uveitis | Placebo for Norflo Oro | IOP change (left eye) | -0.09 | Standard Deviation 2.37 | mmHg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Norflo Oro | 25 | |
| Overall Study | STARTED | Placebo for Norflo Oro | 24 | |
| Overall Study | COMPLETED | Norflo Oro | 18 | |
| Overall Study | COMPLETED | Placebo for Norflo Oro | 23 | |
| Overall Study | NOT COMPLETED | Norflo Oro | 7 | |
| Overall Study | NOT COMPLETED | Placebo for Norflo Oro | 1 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | eye disorders | Eye disorders | Norflo Oro | 4 | 20 | 16 |
| other | eye disorders | Eye disorders | Placebo for Norflo Oro | 7 | 24 | 13 |
| other | gastrointestinal disorders | Gastrointestinal disorders | Norflo Oro | 12 | 20 | 34 |
| other | gastrointestinal disorders | Gastrointestinal disorders | Placebo for Norflo Oro | 10 | 24 | 18 |
| other | General disorders and administration site conditions | General disorders | Norflo Oro | 4 | 20 | 4 |
| other | General disorders and administration site conditions | General disorders | Placebo for Norflo Oro | 3 | 24 | 4 |
| other | Infections and infestations | Infections and infestations | Norflo Oro | 8 | 20 | 16 |
| other | Infections and infestations | Infections and infestations | Placebo for Norflo Oro | 8 | 24 | 14 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Norflo Oro | 4 | 20 | 4 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Placebo for Norflo Oro | 2 | 24 | 3 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Norflo Oro | 0 | 20 |
| Total, all-cause mortality | Placebo for Norflo Oro | 0 | 24 |
| Total, other adverse events | Norflo Oro | 20 | 20 |
| Total, other adverse events | Placebo for Norflo Oro | 19 | 24 |
| Total, serious adverse events | Norflo Oro | 3 | 20 |
| Total, serious adverse events | Placebo for Norflo Oro | 0 | 24 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Norflo Oro vs Placebo for Norflo Oro: deaths from any cause | Trial comparisons |
| Norflo Oro vs Placebo for Norflo Oro: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03584724
GET https://conductscience.org/api/trials/v1/NCT03584724/events?page=2