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The purpose of this study is to determine if SAF312 eye drops have an adequate safety and efficacy profile to justify further clinical development for the treatment of ocular pain associated with corneal epithelial defect such as after photorefractive keratectomy (PRK) surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental |
| |
| Treatment Sequence 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAF312 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pre-dose Pain Assessment | VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain | 6 hours |
| Average Ocular Pain VAS Assessments | VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication) | Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication) | 6,12, 24, 48 and 72 hours post-operatievly |
| VAS Pain Assessments |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chevy Chase | Maryland | 20815 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36729473 | Derived | Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Bilateral crossover design: A crossover design was utilized in order to decrease the inter-patient variability due to different pain tolerance in different individuals.
A total of 40 patients were randomized in a 1:1 ratio to two treatment sequences: SAF312 followed by Vehicle, or Vehicle followed by SAF312.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1 | Vehicle/SAF312 |
| FG001 | Treatment Sequence 2 | SAF312 / Vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1 | Vehicle/SAF312 |
| BG001 | Treatment Sequence 2 | SAF312 / Vehicle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Analog Scale (VAS) Pre-dose Pain Assessment | VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain | Primary PD Analysis set | Posted | Mean | Standard Error | score on a scale | 6 hours |
|
approximately 15 months
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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 | SAF312 | treatment participants from both sequences | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.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 | Apr 11, 2017 | Mar 21, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2018 | Mar 21, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D058447 | Eye Pain |
| ID | Term |
|---|---|
| D005132 | Eye Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
|
VAS pain assessment during the first 72 hours post-operatively. VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain |
| 72 hours |
| Plasma Concentration of SAF312 | C Max | day1, day 4 |
| Sioux Falls |
| South Dakota |
| 57108 |
| United States |
| Novartis Investigative Site | Draper | Utah | 84020 | United States |
| Novartis Investigative Site | Norfolk | Virginia | 23502 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Ethnicity | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Average Ocular Pain VAS Assessments | VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain | Primary PD Analysis set | Posted | Mean | Standard Error | score on a scale | 12 hours |
|
|
|
|
| Secondary | Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication) | Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication) | Secondary PD analysis set | Posted | Count of Participants | Participants | 6,12, 24, 48 and 72 hours post-operatievly |
|
|
|
| Secondary | VAS Pain Assessments | VAS pain assessment during the first 72 hours post-operatively. VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain | Primary PD Analysis set | Posted | Mean | Standard Error | score on a scale | 72 hours |
|
|
|
| Secondary | Plasma Concentration of SAF312 | C Max | PK Analysis set | Posted | Mean | Standard Deviation | ng/mL | day1, day 4 |
|
|
|
| 40 |
| 0 |
| 40 |
| 8 |
| 40 |
| EG001 | Vehicle | Vehicle | 0 | 40 | 0 | 40 | 5 | 40 |
| Corneal infiltrates | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Corneal opacity | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| 0-24 hours post-operatively |
|
| 0-48 hours post-operatively |
|
| 0-72 hours post-operatively |
|
| day 4 |
|
|