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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
Following ophthalmic surgery, the current standard of care includes a topical ophthalmic corticosteroid or other anti-inflammatory agent to treat ocular inflammation and improve patient comfort. If left untreated, inflammation of the eye may result in further ocular complications including scarring, vision loss, or blindness. Although the exact dosing regimen is physician-dependent, patients are typically prescribed a topical corticosteroid for a period of 2-4 weeks following surgery, being tapered over the course of delivery as the inflammation subsides. Topical anti-inflammatory agents are usually administered multiple times per day, particularly in the early period following ophthalmic surgery. Continuing efforts in drug development aim to identify alternatives to ophthalmic corticosteroid use, due to their well-known local and systemic negative side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omaveloxolone Ophthalmic Suspension 1.0% | Experimental | Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery |
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| Omaveloxolone Ophthalmic Suspension 0.5% | Experimental | Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery |
|
| Placebo | Placebo Comparator | Patients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omaveloxolone Ophthalmic Suspension 1.0% | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Anterior Chamber Cells at Day 15 (Visit 5) | Count of participants who had absence of anterior chamber cells at Day 15. White blood cells were counted. In a healthy eye, the anterior chamber should not have any blood cells present. "Yes" indicates an absence of anterior chamber cells. Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward. | 15 days after the participant receives the first dose |
| Absence of Ocular Pain at Day 4 (Visit 3) | Participants were asked to report their pain on Day 4 using the Numerical Pain Rating Scale (NPRS) for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from "0" representing "no pain" to "10" representing the "worst pain imaginable". Lower scores indicate less pain. Participants reporting '0' were recorded as "Yes" while patients reporting any other pain score were recorded as "No". Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward. | 4 days after the participant receives the first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garden Grove | California | 92843 | United States | |||
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Title | Description |
|---|---|---|
| FG000 | Omaveloxolone Ophthalmic Suspension 1.0% | Patients received a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Ophthalmic Suspension 1.0% |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Feb 10, 2014 | Feb 27, 2023 |
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| Omaveloxolone Opthalmic Suspension 0.5% |
| Drug |
|
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| Placebo | Drug |
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| Fort Myers |
| Florida |
| 33907 |
| United States |
| Kansas City | Missouri | 64133 | United States |
| Elizabeth City | North Carolina | 27909 | United States |
| Austin | Texas | 78731 | United States |
| Houston | Texas | 75022 | United States |
| Omaveloxolone Ophthalmic Suspension 0.5% |
Patients received a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Opthalmic Suspension 0.5% |
| FG002 | Placebo | Patients received a single drop of vehicle for Omaveloxolone Ophthalmic suspension instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Placebo |
| Completed Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat population (all randomized patients with available data)
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| ID | Title | Description |
|---|---|---|
| BG000 | Omaveloxolone Ophthalmic Suspension 1.0% | Patients received a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Ophthalmic Suspension 1.0% |
| BG001 | Omaveloxolone Ophthalmic Suspension 0.5% | Patients received a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Opthalmic Suspension 0.5% |
| BG002 | Placebo | Patients received a single drop of vehicle for Omaveloxolone Ophthalmic suspension instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Placebo |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Absence of Anterior Chamber Cells at Day 15 (Visit 5) | Count of participants who had absence of anterior chamber cells at Day 15. White blood cells were counted. In a healthy eye, the anterior chamber should not have any blood cells present. "Yes" indicates an absence of anterior chamber cells. Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward. | Intent-to-treat population (all randomized patients with available data). Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward. | Posted | Count of Participants | Participants | 15 days after the participant receives the first dose |
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| Primary | Absence of Ocular Pain at Day 4 (Visit 3) | Participants were asked to report their pain on Day 4 using the Numerical Pain Rating Scale (NPRS) for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from "0" representing "no pain" to "10" representing the "worst pain imaginable". Lower scores indicate less pain. Participants reporting '0' were recorded as "Yes" while patients reporting any other pain score were recorded as "No". Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward. | Intent-to-treat population (all randomized patients with available data). | Posted | Count of Participants | Participants | 4 days after the participant receives the first dose |
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From Day 1 (24 +/- 6 hours after surgery) to Day 21
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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 | Omaveloxolone Ophthalmic Suspension 1.0%: Study Eye | Patients received a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery. This arm describes adverse events in the study eye only. Omaveloxolone Ophthalmic Suspension 1.0% | 0 | 37 | 0 | 37 | 18 | 37 |
| EG001 | Omaveloxolone Ophthalmic Suspension 1.0%: Non-study Eye | Patients received a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery. This arm describes adverse events in the non-study eye only. Omaveloxolone Ophthalmic Suspension 1.0% | 0 | 37 | 0 | 37 | 0 | 37 |
| EG002 | Omaveloxolone Ophthalmic Suspension 0.5%: Study Eye | Patients received a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery This arm describes adverse events in the study eye only. Omaveloxolone Ophthalmic Suspension 0.5% | 0 | 33 | 0 | 33 | 15 | 33 |
| EG003 | Omaveloxolone Ophthalmic Suspension 0.5%: Non-study Eye | Patients received a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery This arm describes adverse events in the non-study eye only. Omaveloxolone Ophthalmic Suspension 0.5% | 0 | 33 | 0 | 33 | 2 | 33 |
| EG004 | Placebo: Study Eye | Patients received a single drop of vehicle for Omaveloxolone Ophthalmic suspension instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery This arm describes adverse events in the study eye only. Placebo | 0 | 39 | 0 | 39 | 13 | 39 |
| EG005 | Placebo: Non-study Eye | Patients received a single drop of vehicle for Omaveloxolone Ophthalmic suspension instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery This arm describes adverse events in the non-study eye only. Placebo | 0 | 39 | 0 | 39 | 1 | 39 |
| EG006 | Omaveloxolone Ophthalmic Suspension 1.0%: Non-ocular AE | Patients received a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery This arm describes non-ocular adverse events only. Omaveloxolone Ophthalmic Suspension 1.0% | 0 | 37 | 0 | 37 | 2 | 37 |
| EG007 | Omaveloxolone Ophthalmic Suspension 0.5%: Non-ocular AE | Patients received a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery This arm describes non-ocular adverse events only. Omaveloxolone Ophthalmic Suspension 0.5% | 0 | 33 | 0 | 33 | 2 | 33 |
| EG008 | Placebo: Non-ocular AE | Patients received a single drop of vehicle for Omaveloxolone Ophthalmic suspension instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery This arm describes non-ocular adverse events only. Placebo | 0 | 39 | 0 | 39 | 1 | 39 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber pigmentation | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Ciliary hyperaemia | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Corneal deposits | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Corneal disorder | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Corneal pigmentation | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Corneal striae | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Cystoid macular oedema | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Lenticular opacities | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Instillation site pain | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
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Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2014 | Feb 27, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D058447 | Eye Pain |
| D009877 | Endophthalmitis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005132 | Eye Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D015817 | Eye Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000589490 | omaveloxolone |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|
p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided. |
| 0.2297 |
| Difference in proportion of patients |
| 8.2 |
| 2-Sided |
| 95 |
| -13.5 |
| 29.8 |
| Superiority |
| OG002 | Placebo | Patients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Placebo |
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