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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005857-97 | EudraCT Number |
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The study was designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (5 mg/mL and 15 mg/mL) in subjects with CICP persisting at least for 4 months after refractive or cataract surgery and chronicity confirmed during the observational period. The study also determined the optimal dose to carry forward for further development.
This was a Phase II randomized, double-masked, multi-center, parallel group, placebo-controlled study to evaluate the safety and efficacy of SAF312, 5 mg/mL and 15 mg/mL eye drops versus Placebo used twice-daily in both eyes for 12 weeks. The study consisted of a 12-week observation period starting from Screening Visit (Visit 1) until the Baseline/Randomization Visit (Visit 2). Subjects who met eligibility criteria at Visit 2 were randomized to one of the three treatment arms (SAF312 5 mg/mL, SAF312 15 mg/mL, Placebo) in a 1:1:1 ratio. Subjects who qualified for randomization had visits every 2 weeks for the first 4 weeks, and then monthly visits for the remainder of the 12-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAF312 Placebo | Placebo Comparator | Randomized to a 1:1:1 topical eye drops, twice daily |
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| SAF312 5 mg/mL | Experimental | Randomized to a 1:1:1 topical eye drops, twice daily |
|
| SAF312 15 mg/mL | Experimental | Randomized to a 1:1:1 topical eye drops, twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAF312 Placebo | Other | Topical ocular, suspension eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS) | The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome. |
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Key Inclusion Criteria:
At Baseline
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Valley Eye Medical Group | Mission Hills | California | 91345 | United States | ||
| NVISION Eye Centers |
| 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 www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
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| ID | Title | Description |
|---|---|---|
| FG000 | SAF312 15 mg/mL | Randomized to a 1:1:1 topical eye drops, twice daily |
| FG001 | SAF312 5 mg/mL | Randomized to a 1:1:1 topical eye drops, twice daily |
| 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 | Oct 6, 2021 | Mar 22, 2024 |
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Double-blinded
| SAF312 | Drug | Topical ocular, suspension eye drops |
|
| Baseline, Days 7 and 14 |
| Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | The pain frequency Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Frequent' pain on the right) to score the frequency of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain frequency. A negative change from baseline is a positive outcome. | Baseline, Weeks 1 to 12 |
| Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Each question in the Ocular Pain Assessment Survey (OPAS) quality of life subscale was scored by the subject on a line marked from 0 (not at all) to 10 (completely) that described how much pain interfered with or affected a particular activity (max score= 10/question). A higher score suggests a higher impact by pain on a particular activity. A negative change from baseline is a positive outcome. There are 7 questions in total regarding Quality of Life. The average score of the 7 Quality of Life questions is reported (mean (SD)). | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Conjunctival redness in each of two regions (nasal and temporal) was graded on a scale from 0 to 5 using the McMonnies conjunctival redness photographic scale (max score=5/region). Higher scores suggest higher degrees of redness (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Conjunctival redness in each of two regions (nasal and temporal) was graded on a scale from 0 to 5 using the McMonnies conjunctival redness photographic scale (max score=5/region). Higher scores suggest higher degrees of redness (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome. A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Conjunctival redness in each of two regions (nasal and temporal) was graded on a scale from 0 to 5 using the McMonnies conjunctival redness photographic scale (max score=5/region). Higher scores suggest higher degrees of redness (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | The degree of lissamine conjunctival staining in two regions (temporal and nasal) was graded on a scale from 0 to 4 (max score = 8/eye). Higher scores suggest higher degrees of corneal staining (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | The degree of lissamine conjunctival staining in two regions (temporal and nasal) was graded on a scale from 0 to 4 (max score = 8/eye). Higher scores suggest higher degrees of corneal staining (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | The degree of corneal fluorescein staining in each of five regions (superior, inferior, nasal, temporal, and central) was graded on a scale from 0 to 4 (max score=20/eye). Higher scores suggest higher degrees of corneal staining (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | The degree of corneal fluorescein staining in each of five regions (superior, inferior, nasal, temporal, and central) was graded on a scale from 0 to 4 (max score=20/eye). Higher scores suggest higher degrees of corneal staining (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | The Schirmer's test was performed without anesthetic. Tear secretion was measured in millimeters based on the length of strip wetted by tears (max score =35 mm/eye). Lower values indicate lower relative amounts of tear secretion (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | The Schirmer's test was performed without anesthetic. Tear secretion was measured in millimeters based on the length of strip wetted by tears (max score =35 mm/eye). Lower values indicate lower relative amounts of tear secretion (worsening). A negative change from baseline is a positive outcome. | Baseline, Weeks 2, 4, 8, 12 |
| Number of Participants With Treatment Emergent Adverse Events | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months). |
| Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. MedDRA Version 26.0 was used for the reporting of adverse events. | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months). |
| Summary of Non-ocular Treatment Emergent Adverse Events | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months). |
| Newport Beach |
| California |
| 92660 |
| United States |
| Stanford Eye Laser Center | Palo Alto | California | 94303 | United States |
| Gordon Schanzlin New Vision Inst | San Diego | California | 92122 | United States |
| Novartis Investigative Site | Coral Springs | Florida | 33067 | United States |
| Novartis Investigative Site | Jacksonville | Florida | 32256 | United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Boston Sight | Needham | Massachusetts | 02494 | United States |
| Univ of MI Kellogg Eye Center . | Ann Arbor | Michigan | 48105 | United States |
| Duke Univ Medical Center Ophthalmology | Durham | North Carolina | 27710 | United States |
| Bergstrom Eye Research LLC | Fargo | North Dakota | 58103 | United States |
| University of Pennsylvania . | Philadelphia | Pennsylvania | 19104 | United States |
| Chattanooga Eye Institute | Chattanooga | Tennessee | 37411 | United States |
| Novartis Investigative Site | Memphis | Tennessee | 38119 | United States |
| Advancing Vision Research LLC | Smyrna | Tennessee | 37167 | United States |
| Novartis Investigative Site | Houston | Texas | 77025 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Houston | Texas | 77074 | United States |
| Lake Travis Eye and Laser Ctr | Lakeway | Texas | 78738 | United States |
| Stacy R Smith MD PC | Salt Lake City | Utah | 84117 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| Rainier Clinical Research Center Inc . | Renton | Washington | 98057 | United States |
| Periman Eye Institute | Seattle | Washington | 98119 | United States |
| Novartis Investigative Site | Sapporo | Hokkaido | 060 8648 | Japan |
| Novartis Investigative Site | Shinagawa | Tokyo | 141-0022 | Japan |
| Novartis Investigative Site | Birmingham | West Midlands | B75 6QW | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| FG002 | SAF312 Placebo | Randomized to a 1:1:1 topical eye drops, twice daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SAF312 15 mg/mL | Randomized to a 1:1:1 topical eye drops, twice daily |
| BG001 | SAF312 5 mg/mL | Randomized to a 1:1:1 topical eye drops, twice daily |
| BG002 | SAF312 Placebo | Randomized to a 1:1:1 topical eye drops, twice daily |
| 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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| 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 | Change From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS) | The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome. | Full Analysis Set - all treated patients | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 12 |
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| Secondary | Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Days 7 and 14 |
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| Secondary | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | The pain frequency Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Frequent' pain on the right) to score the frequency of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain frequency. A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 1 to 12 |
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| Secondary | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Each question in the Ocular Pain Assessment Survey (OPAS) quality of life subscale was scored by the subject on a line marked from 0 (not at all) to 10 (completely) that described how much pain interfered with or affected a particular activity (max score= 10/question). A higher score suggests a higher impact by pain on a particular activity. A negative change from baseline is a positive outcome. There are 7 questions in total regarding Quality of Life. The average score of the 7 Quality of Life questions is reported (mean (SD)). | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Conjunctival redness in each of two regions (nasal and temporal) was graded on a scale from 0 to 5 using the McMonnies conjunctival redness photographic scale (max score=5/region). Higher scores suggest higher degrees of redness (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Conjunctival redness in each of two regions (nasal and temporal) was graded on a scale from 0 to 5 using the McMonnies conjunctival redness photographic scale (max score=5/region). Higher scores suggest higher degrees of redness (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome. A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Conjunctival redness in each of two regions (nasal and temporal) was graded on a scale from 0 to 5 using the McMonnies conjunctival redness photographic scale (max score=5/region). Higher scores suggest higher degrees of redness (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | The degree of lissamine conjunctival staining in two regions (temporal and nasal) was graded on a scale from 0 to 4 (max score = 8/eye). Higher scores suggest higher degrees of corneal staining (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | The degree of lissamine conjunctival staining in two regions (temporal and nasal) was graded on a scale from 0 to 4 (max score = 8/eye). Higher scores suggest higher degrees of corneal staining (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | The degree of corneal fluorescein staining in each of five regions (superior, inferior, nasal, temporal, and central) was graded on a scale from 0 to 4 (max score=20/eye). Higher scores suggest higher degrees of corneal staining (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | The degree of corneal fluorescein staining in each of five regions (superior, inferior, nasal, temporal, and central) was graded on a scale from 0 to 4 (max score=20/eye). Higher scores suggest higher degrees of corneal staining (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | The Schirmer's test was performed without anesthetic. Tear secretion was measured in millimeters based on the length of strip wetted by tears (max score =35 mm/eye). Lower values indicate lower relative amounts of tear secretion (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | The Schirmer's test was performed without anesthetic. Tear secretion was measured in millimeters based on the length of strip wetted by tears (max score =35 mm/eye). Lower values indicate lower relative amounts of tear secretion (worsening). A negative change from baseline is a positive outcome. | Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 2, 4, 8, 12 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Safety set | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months). |
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| Secondary | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. MedDRA Version 26.0 was used for the reporting of adverse events. | Safety set | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months). |
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| Secondary | Summary of Non-ocular Treatment Emergent Adverse Events | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Safety set | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months). |
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Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 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 15 mg/mL | Randomized to a 1:1:1 topical eye drops, twice daily | 0 | 50 | 0 | 50 | 21 | 50 |
| EG001 | SAF312 5 mg/mL | Randomized to a 1:1:1 topical eye drops, twice daily | 0 | 49 | 0 | 49 | 12 | 49 |
| EG002 | SAF312 Placebo | Randomized to a 1:1:1 topical eye drops, twice daily | 0 | 51 | 1 | 51 | 18 | 51 |
| EG003 | Total | Total | 0 | 150 | 1 | 150 | 51 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Conjunctival papillae | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dry age-related macular degeneration | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Optic nerve cupping | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Instillation site irritation | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Instillation site pruritus | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Medical device site irritation | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Therapy responder | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Buttock injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diabetic bullosis | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | 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 (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2023 | Mar 22, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058447 | Eye Pain |
| ID | Term |
|---|---|
| D005132 | Eye Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mixed Models Analysis |
mixed-model repeated measures (MMRM) analysis |
| 0.699 |
Reporting the adjusted p-value derived based on Dunett procedure. |
| Least Square (LS) mean difference |
| 3.7 |
| Standard Error of the Mean |
| 5.11 |
| 2-Sided |
| 95 |
| -6.4 |
| 13.8 |
| Superiority |
| Units | Counts |
|---|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|