Chronic Ocular Pain
Conditions
Keywords
Eye pain, Dry eye like symptoms, Ocular surface pain, Corneal induced chronic pain, neuropathic eye pain, post-operative corneal induced chronic pain, CICP, corneal, corneal pain
Brief summary
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.
Detailed description
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.
Interventions
OTHERSAF312 Placebo
Topical ocular, suspension eye drops
DRUGSAF312
Topical ocular, suspension eye drops
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects who have undergone refractive surgery (i.e., PRK, LASIK, LASEK, RK, or SMILE) in both eyes or cataract surgery in both eyes, with or without refractive enhancement in one or both eyes, ≥4 months prior to Screening Visit and experiencing persistent ocular surface pain since the surgery, and have been seen by an ophthalmologist or optometrist at least once with complaint of continued ocular pain since surgery. * Subjects who demonstrate a ≥ 60% reduction in ocular pain within 5 minutes after instillation of a single topical ocular anesthetic drop at Screening Visit. At Baseline * Subjects with an average pain severity VAS score of ≥ 30 mm based on Daily eDiary for the last 7 days prior to Baseline Visit. * Subjects who have reported pain severity \>10 mm based on Daily eDiary for \> 50% of the days of the observational period (Screening) Key
Exclusion criteria
* Use of nerve growth factor eye drops within 14 days of the Screening Visit * Seasonal allergic conjunctivitis, or other acute or seasonal ocular diagnosis that are active at the time of Screening or would be active during the course of the study. * Any history of ocular herpes simplex virus or herpes zoster virus infection, or other severe ocular conditions such as graft versus host disease, Stevens-Johnson syndrome or sarcoidosis. * Presence of any ocular infection (bacterial, viral, or fungal) within 30 days prior to Screening. * Chronic topical ocular medications (ie. cyclosporine, lifitegrast) initiated \<6 months prior to Screening Visit, or any anticipated change during the study. * Use of ocular or nasal corticosteroids within 30 days of Screening Visit. * Use of neuromodulatory medications (eg, gabapentin, pregabalin) or opioid use for non-ocular pain within 30 days of Screening Visit. * Chronic medications (both over the counter and prescription) that have not been stable for at least 30 days prior to Screening Visit, or any anticipated change in the chronic medication regimen. * Subjects requiring hospitalization within 6 months prior to screening for severe psychiatric disorders (e.g. psychosis, schizophrenia, mania, depression) or major psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS) | Baseline, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Baseline, Weeks 1 to 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. |
| Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Baseline, Weeks 2, 4, 8, 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)). |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | Baseline, Days 7 and 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
| Number of Participants With Treatment Emergent 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). | 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. |
| Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | 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). | 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. |
| Summary of Non-ocular Treatment Emergent 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). | 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. |
| Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Baseline, Weeks 2, 4, 8, 12 | 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. |
Countries
Japan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SAF312 15 mg/mL Randomized to a 1:1:1 topical eye drops, twice daily | 50 |
| SAF312 5 mg/mL Randomized to a 1:1:1 topical eye drops, twice daily | 49 |
| SAF312 Placebo Randomized to a 1:1:1 topical eye drops, twice daily | 51 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 |
| Overall Study | Physician Decision | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | SAF312 15 mg/mL | SAF312 5 mg/mL | SAF312 Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 15.56 | 60.4 years STANDARD_DEVIATION 15.12 | 56.8 years STANDARD_DEVIATION 17.15 | 59.4 years STANDARD_DEVIATION 15.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 49 Participants | 48 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 9 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 4 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 37 Participants | 38 Participants | 110 Participants |
| Sex: Female, Male Female | 35 Participants | 34 Participants | 40 Participants | 109 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 11 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 | 0 / 51 | 0 / 150 |
| other Total, other adverse events | 21 / 50 | 12 / 49 | 18 / 51 | 51 / 150 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 | 1 / 51 | 1 / 150 |
Outcome results
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.
Time frame: Baseline, Week 12
Population: Full Analysis Set - all treated patients
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SAF312 15 mg/mL | Change From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS) | -23.7 Scores on a scale | Standard Error 3.7 |
| SAF312 5mg/mL | Change From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS) | -21.7 Scores on a scale | Standard Error 3.71 |
| SAF312 Placebo | Change From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS) | -25.3 Scores on a scale | Standard Error 3.51 |
p-value: 0.9395% CI: [-8.5, 11.7]Mixed Models Analysis
p-value: 0.69995% CI: [-6.4, 13.8]Mixed Models Analysis
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.
Time frame: 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).
Population: Safety set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related ocular serious adverse events | 0 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any ocular adverse events leading to study drug discontinuation | 0 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any serious adverse events | 0 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any adverse events leading to study drug discontinuation | 1 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any study drug related adverse events | 5 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | Death | 0 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related non-ocular adverse events | 0 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related ocular adverse events | 5 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any adverse events | 21 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any ocular adverse events | 11 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related non-ocular serious adverse events | 0 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular adverse events | 13 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any study drug related serious adverse events | 0 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any ocular serious adverse events | 0 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular adverse events leading to study drug discontinuation | 1 Participants |
| SAF312 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular serious adverse events | 0 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related ocular adverse events | 5 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any adverse events | 12 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any serious adverse events | 0 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any ocular serious adverse events | 0 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any ocular adverse events leading to study drug discontinuation | 1 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular adverse events | 4 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular serious adverse events | 0 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related non-ocular adverse events | 1 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any study drug related adverse events | 5 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any adverse events leading to study drug discontinuation | 1 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular adverse events leading to study drug discontinuation | 1 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | Any study drug related serious adverse events | 0 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related ocular serious adverse events | 0 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related non-ocular serious adverse events | 0 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | Death | 0 Participants |
| SAF312 5mg/mL | Number of Participants With Treatment Emergent Adverse Events | -Any ocular adverse events | 10 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any ocular serious adverse events | 0 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | Death | 0 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular adverse events leading to study drug discontinuation | 1 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | Any serious adverse events | 1 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related non-ocular serious adverse events | 0 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | Any study drug related serious adverse events | 0 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular adverse events | 13 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | Any adverse events | 18 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related ocular serious adverse events | 0 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related ocular adverse events | 2 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | Any study drug related adverse events | 2 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any study drug related non-ocular adverse events | 0 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any ocular adverse events | 10 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | Any adverse events leading to study drug discontinuation | 1 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any non-ocular serious adverse events | 1 Participants |
| SAF312 Placebo | Number of Participants With Treatment Emergent Adverse Events | -Any ocular adverse events leading to study drug discontinuation | 0 Participants |
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)).
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 4 (n=46,46,49) | -1.68 Scores on a scale | Standard Deviation 2.36 |
| SAF312 15 mg/mL | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 12 (n=45,45,45) | -2.20 Scores on a scale | Standard Deviation 2.317 |
| SAF312 15 mg/mL | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 8 (n=47,45,45) | -1.61 Scores on a scale | Standard Deviation 2.428 |
| SAF312 15 mg/mL | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 2 (n=48,46,46) | -1.39 Scores on a scale | Standard Deviation 1.839 |
| SAF312 5mg/mL | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 4 (n=46,46,49) | -1.39 Scores on a scale | Standard Deviation 2.04 |
| SAF312 5mg/mL | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 2 (n=48,46,46) | -0.99 Scores on a scale | Standard Deviation 2.027 |
| SAF312 5mg/mL | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 12 (n=45,45,45) | -1.79 Scores on a scale | Standard Deviation 2.225 |
| SAF312 5mg/mL | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 8 (n=47,45,45) | -1.30 Scores on a scale | Standard Deviation 2.103 |
| SAF312 Placebo | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 2 (n=48,46,46) | -1.52 Scores on a scale | Standard Deviation 1.704 |
| SAF312 Placebo | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 12 (n=45,45,45) | -2.06 Scores on a scale | Standard Deviation 2.284 |
| SAF312 Placebo | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 8 (n=47,45,45) | -1.82 Scores on a scale | Standard Deviation 1.805 |
| SAF312 Placebo | Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12 | Week 4 (n=46,46,49) | -2.00 Scores on a scale | Standard Deviation 2.138 |
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.
Time frame: Baseline, Weeks 1 to 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 3 (n=49,47,49) | -17.35 Scores on a scale | Standard Deviation 21.332 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 1 | -10.22 Scores on a scale | Standard Deviation 16.404 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 2 (n=49,48,50) | -14.38 Scores on a scale | Standard Deviation 21.073 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 4 (n=49,46,48) | -19.06 Scores on a scale | Standard Deviation 23.07 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 5 (n=49,46,48) | -20.34 Scores on a scale | Standard Deviation 24.524 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 6 (n=48,47,48) | -19.84 Scores on a scale | Standard Deviation 25.511 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 7 (n=47,47,48) | -22.84 Scores on a scale | Standard Deviation 25.774 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 8 (n-47,45,48) | -23.25 Scores on a scale | Standard Deviation 26.009 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 9 (n=46,44,48) | -24.30 Scores on a scale | Standard Deviation 25.65 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 10 (n=46,44,47) | -25.16 Scores on a scale | Standard Deviation 25.381 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 11 (n=46,45,47) | -26.62 Scores on a scale | Standard Deviation 26.057 |
| SAF312 15 mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 12 (n=46,43,47) | -26.24 Scores on a scale | Standard Deviation 25.322 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 12 (n=46,43,47) | -20.38 Scores on a scale | Standard Deviation 24.296 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 9 (n=46,44,48) | -18.01 Scores on a scale | Standard Deviation 25.04 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 1 | -9.96 Scores on a scale | Standard Deviation 15.464 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 7 (n=47,47,48) | -17.60 Scores on a scale | Standard Deviation 24.715 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 6 (n=48,47,48) | -15.60 Scores on a scale | Standard Deviation 23.332 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 2 (n=49,48,50) | -12.68 Scores on a scale | Standard Deviation 20.344 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 11 (n=46,45,47) | -21.68 Scores on a scale | Standard Deviation 24.754 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 3 (n=49,47,49) | -14.75 Scores on a scale | Standard Deviation 23.314 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 8 (n-47,45,48) | -17.40 Scores on a scale | Standard Deviation 23.636 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 5 (n=49,46,48) | -14.31 Scores on a scale | Standard Deviation 23.711 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 4 (n=49,46,48) | -12.75 Scores on a scale | Standard Deviation 24.076 |
| SAF312 5mg/mL | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 10 (n=46,44,47) | -18.44 Scores on a scale | Standard Deviation 24.387 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 4 (n=49,46,48) | -24.07 Scores on a scale | Standard Deviation 25.23 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 5 (n=49,46,48) | -26.18 Scores on a scale | Standard Deviation 22.404 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 10 (n=46,44,47) | -25.72 Scores on a scale | Standard Deviation 26.428 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 6 (n=48,47,48) | -23.88 Scores on a scale | Standard Deviation 25.433 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 7 (n=47,47,48) | -25.09 Scores on a scale | Standard Deviation 24.489 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 8 (n-47,45,48) | -24.69 Scores on a scale | Standard Deviation 26.072 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 11 (n=46,45,47) | -25.66 Scores on a scale | Standard Deviation 28.343 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 1 | -12.45 Scores on a scale | Standard Deviation 15.484 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 9 (n=46,44,48) | -24.92 Scores on a scale | Standard Deviation 25.648 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 2 (n=49,48,50) | -18.80 Scores on a scale | Standard Deviation 20.489 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 3 (n=49,47,49) | -22.45 Scores on a scale | Standard Deviation 22.98 |
| SAF312 Placebo | Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12 | Week 12 (n=46,43,47) | -26.98 Scores on a scale | Standard Deviation 25.977 |
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.
Time frame: Baseline, Days 7 and 14
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | Day 7 (n=45,44,43) | -10.89 Scores on a scale | Standard Deviation 18.373 |
| SAF312 15 mg/mL | Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | Day 14 (n=45,37,44) | -12.20 Scores on a scale | Standard Deviation 21.484 |
| SAF312 5mg/mL | Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | Day 7 (n=45,44,43) | -11.45 Scores on a scale | Standard Deviation 20.661 |
| SAF312 5mg/mL | Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | Day 14 (n=45,37,44) | -14.89 Scores on a scale | Standard Deviation 25.79 |
| SAF312 Placebo | Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | Day 7 (n=45,44,43) | -17.40 Scores on a scale | Standard Deviation 21.558 |
| SAF312 Placebo | Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14 | Day 14 (n=45,37,44) | -21.00 Scores on a scale | Standard Deviation 21.624 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | -0.1 Scores on a scale | Standard Deviation 0.75 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | -0.2 Scores on a scale | Standard Deviation 0.77 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,43,42) | -0.2 Scores on a scale | Standard Deviation 0.72 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | -0.2 Scores on a scale | Standard Deviation 0.7 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | -0.0 Scores on a scale | Standard Deviation 0.75 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | -0.0 Scores on a scale | Standard Deviation 0.43 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,43,42) | -0.1 Scores on a scale | Standard Deviation 0.68 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | -0.0 Scores on a scale | Standard Deviation 0.67 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | -0.1 Scores on a scale | Standard Deviation 0.76 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | 0.0 Scores on a scale | Standard Deviation 0.52 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,43,42) | -0.2 Scores on a scale | Standard Deviation 0.62 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | -0.1 Scores on a scale | Standard Deviation 0.65 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | -0.2 Scores on a scale | Standard Deviation 0.67 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 4 (N=44,45,46) | -0.3 Scores on a scale | Standard Deviation 0.78 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,43,42) | -0.2 Scores on a scale | Standard Deviation 0.7 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.2 Scores on a scale | Standard Deviation 0.68 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 4 (N=44,45,46) | 0.0 Scores on a scale | Standard Deviation 0.67 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,43,42) | -0.2 Scores on a scale | Standard Deviation 0.73 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.1 Scores on a scale | Standard Deviation 0.59 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | -0.1 Scores on a scale | Standard Deviation 0.45 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | -0.2 Scores on a scale | Standard Deviation 0.61 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 4 (N=44,45,46) | -0.1 Scores on a scale | Standard Deviation 0.41 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.2 Scores on a scale | Standard Deviation 0.83 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,43,42) | -0.2 Scores on a scale | Standard Deviation 0.61 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | -0.3 Scores on a scale | Standard Deviation 0.83 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,43,42) | -0.2 Scores on a scale | Standard Deviation 0.84 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | -0.2 Scores on a scale | Standard Deviation 0.72 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | -0.3 Scores on a scale | Standard Deviation 0.78 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | -0.1 Scores on a scale | Standard Deviation 0.73 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | 0.1 Scores on a scale | Standard Deviation 0.55 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | 0.0 Scores on a scale | Standard Deviation 0.71 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,43,42) | -0.1 Scores on a scale | Standard Deviation 0.8 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | -0.3 Scores on a scale | Standard Deviation 0.99 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | -0.1 Scores on a scale | Standard Deviation 0.57 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,43,42) | -0.2 Scores on a scale | Standard Deviation 0.76 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | -0.1 Scores on a scale | Standard Deviation 0.68 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,43,42) | -0.2 Scores on a scale | Standard Deviation 0.67 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | -0.2 Scores on a scale | Standard Deviation 0.74 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.3 Scores on a scale | Standard Deviation 0.71 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 4 (n=44,45,46) | -0.4 Scores on a scale | Standard Deviation 0.81 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | 0.0 Scores on a scale | Standard Deviation 0.53 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.1 Scores on a scale | Standard Deviation 0.63 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 4 (n=44,45,46) | 0.1 Scores on a scale | Standard Deviation 0.61 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,43,42) | -0.1 Scores on a scale | Standard Deviation 0.7 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 4 (n=44,45,46) | 0.1 Scores on a scale | Standard Deviation 0.57 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | -0.1 Scores on a scale | Standard Deviation 0.72 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.2 Scores on a scale | Standard Deviation 0.9 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Temporal (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,43,42) | -0.1 Scores on a scale | Standard Deviation 0.69 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | 0.1 Scores on a scale | Standard Deviation 0.99 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | 0.0 Scores on a scale | Standard Deviation 1.27 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,42,42) | -0.2 Scores on a scale | Standard Deviation 1 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | 0.1 Scores on a scale | Standard Deviation 1.39 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | 0.2 Scores on a scale | Standard Deviation 1.62 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | -0.0 Scores on a scale | Standard Deviation 1.23 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,42,42) | 0.0 Scores on a scale | Standard Deviation 1.06 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | -0.1 Scores on a scale | Standard Deviation 1.24 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 8 (n=45,42,42) | 0.3 Scores on a scale | Standard Deviation 1.27 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 4 (n=44,45,46) | -0.2 Scores on a scale | Standard Deviation 1.23 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 12 (n=44,43,44) | 0.0 Scores on a scale | Standard Deviation 1.54 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Dexter (OD) = Right Eye) | Week 2 (n=47,44,43) | -0.1 Scores on a scale | Standard Deviation 1.06 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,42,42) | -0.2 Scores on a scale | Standard Deviation 1.01 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 4 (n=44,45,46) | -0.1 Scores on a scale | Standard Deviation 1.2 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | 0.0 Scores on a scale | Standard Deviation 0.99 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.1 Scores on a scale | Standard Deviation 1.25 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 4 (n=44,45,46) | 0.1 Scores on a scale | Standard Deviation 1.47 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | -0.1 Scores on a scale | Standard Deviation 1.51 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.1 Scores on a scale | Standard Deviation 1.16 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,42,42) | -0.3 Scores on a scale | Standard Deviation 1.32 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 2 (n=47,44,43) | -0.2 Scores on a scale | Standard Deviation 1.41 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 12 (n=44,43,44) | -0.1 Scores on a scale | Standard Deviation 1.25 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 8 (n=45,42,42) | 0.1 Scores on a scale | Standard Deviation 1.46 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Staining (Oculus Sinister (OS) = Left Eye) | Week 4 (n=44,45,46) | -0.1 Scores on a scale | Standard Deviation 1.41 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 4 (n=46,47,49) | -0.8 Scores on a scale | Standard Deviation 2.84 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 2 (n=49,46,46) | -0.6 Scores on a scale | Standard Deviation 2.02 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 8 (n=47,45,45) | -0.9 Scores on a scale | Standard Deviation 2.93 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 12 (n=46,45,47) | -0.7 Scores on a scale | Standard Deviation 3.1 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 12 (n=46,45,47) | -0.1 Scores on a scale | Standard Deviation 1.95 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 2 (n=49,46,46) | -0.7 Scores on a scale | Standard Deviation 1.73 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 4 (n=46,47,49) | -0.1 Scores on a scale | Standard Deviation 2.47 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 8 (n=47,45,45) | -0.6 Scores on a scale | Standard Deviation 2.09 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 12 (n=46,45,47) | -1.5 Scores on a scale | Standard Deviation 2.78 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 8 (n=47,45,45) | -0.8 Scores on a scale | Standard Deviation 2.4 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 2 (n=49,46,46) | -0.7 Scores on a scale | Standard Deviation 2.76 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Dexter (OD) = Right Eye) | Week 4 (n=46,47,49) | -0.9 Scores on a scale | Standard Deviation 2.32 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 12 (n=46,45,47) | -0.9 Scores on a scale | Standard Deviation 3.33 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 8 (n=47,45,45) | -1.2 Scores on a scale | Standard Deviation 3.51 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 4 (n=46,47,49) | -0.7 Scores on a scale | Standard Deviation 2.67 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 2 (n=49,46,46) | -0.5 Scores on a scale | Standard Deviation 2.48 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 8 (n=47,45,45) | -0.8 Scores on a scale | Standard Deviation 2.46 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 4 (n=46,47,49) | -0.6 Scores on a scale | Standard Deviation 2.62 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 2 (n=49,46,46) | -0.7 Scores on a scale | Standard Deviation 2.55 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 12 (n=46,45,47) | -0.5 Scores on a scale | Standard Deviation 2.19 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 4 (n=46,47,49) | -0.6 Scores on a scale | Standard Deviation 2.51 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 2 (n=49,46,46) | -1.0 Scores on a scale | Standard Deviation 2.82 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 12 (n=46,45,47) | -1.5 Scores on a scale | Standard Deviation 3.14 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Corneal Staining (Oculus Sinister (OS) = Left Eye) | Week 8 (n=47,45,45) | -0.9 Scores on a scale | Standard Deviation 2.85 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 2 (n=49,45,46) | -1.1 mm | Standard Deviation 8.38 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 8 (n=47,43,45) | 0.0 mm | Standard Deviation 8.04 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 4 (n=46,47,49) | -0.3 mm | Standard Deviation 7.45 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 12 (n=46,45,47) | -0.7 mm | Standard Deviation 7.79 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 8 (n=47,43,45) | -1.7 mm | Standard Deviation 9.89 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 4 (n=46,47,49) | -1.4 mm | Standard Deviation 7.85 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 12 (n=46,45,47) | -0.9 mm | Standard Deviation 7.02 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 2 (n=49,45,46) | -0.3 mm | Standard Deviation 8.62 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 8 (n=47,43,45) | -1.4 mm | Standard Deviation 8.45 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 12 (n=46,45,47) | 0.9 mm | Standard Deviation 7.77 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 4 (n=46,47,49) | 0.1 mm | Standard Deviation 7.4 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Dexter (OD) = Right Eye) | Week 2 (n=49,45,46) | -0.3 mm | Standard Deviation 7.67 |
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.
Time frame: Baseline, Weeks 2, 4, 8, 12
Population: Participants in the Full Analysis Set with an available value for the outcome measure at baseline and at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 2 (n=49,45,46) | -0.7 mm | Standard Deviation 8.98 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 12 (n=46,45,47) | 0.1 mm | Standard Deviation 9.51 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 4 (n=46,47,49) | 0.7 mm | Standard Deviation 7.52 |
| SAF312 15 mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 8 (n=47,43,45) | 0.2 mm | Standard Deviation 8.3 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 8 (n=47,43,45) | -1.1 mm | Standard Deviation 8.71 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 2 (n=49,45,46) | -1.5 mm | Standard Deviation 7.81 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 4 (n=46,47,49) | -2.1 mm | Standard Deviation 7.78 |
| SAF312 5mg/mL | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 12 (n=46,45,47) | -2.2 mm | Standard Deviation 8.6 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 8 (n=47,43,45) | -0.7 mm | Standard Deviation 6.92 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 12 (n=46,45,47) | 1.1 mm | Standard Deviation 7.88 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 4 (n=46,47,49) | 1.4 mm | Standard Deviation 7.59 |
| SAF312 Placebo | Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week of Tear Production - Schirmer Test (mm) (Oculus Sinister (OS) = Left Eye) | Week 2 (n=49,45,46) | 0.6 mm | Standard Deviation 4.82 |
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.
Time frame: 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).
Population: Safety set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Immune system disorders | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: General disorders and administration site conditions | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Blepharitis | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Vision blurred | 1 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Eye disorders | 10 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Chalazion | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Drug hypersensitivity | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Instillation site pruritus | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Conjunctival papillae | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Infections and infestations | 2 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Injury, poisoning and procedural complications | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Corneal oedema | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Instillation site irritation | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye pain | 3 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Erythema of eyelid | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye irritation | 1 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Corneal abrasion | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Lacrimation increased | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Therapy responder | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Dry eye | 2 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Ocular hyperaemia | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye discharge | 1 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Foreign body in eye | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Optic nerve cupping | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | Number of subjects with at least one event | 11 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye pruritus | 2 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Dry age-related macular degeneration | 1 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Swelling of eyelid | 0 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Vitreous detachment | 1 Participants |
| SAF312 15 mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Hordeolum | 2 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye irritation | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Dry age-related macular degeneration | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: General disorders and administration site conditions | 4 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye discharge | 2 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Instillation site irritation | 2 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Drug hypersensitivity | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Instillation site pruritus | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Therapy responder | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Immune system disorders | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Vision blurred | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Injury, poisoning and procedural complications | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | Number of subjects with at least one event | 10 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Corneal abrasion | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Infections and infestations | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Foreign body in eye | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Vitreous detachment | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Dry eye | 2 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Blepharitis | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Chalazion | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Eye disorders | 8 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Conjunctival papillae | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye pruritus | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Corneal oedema | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Erythema of eyelid | 3 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye pain | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Lacrimation increased | 1 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Ocular hyperaemia | 2 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Hordeolum | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Optic nerve cupping | 0 Participants |
| SAF312 5mg/mL | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Swelling of eyelid | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Infections and infestations | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye pruritus | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Dry age-related macular degeneration | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | Number of subjects with at least one event | 10 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Eye disorders | 10 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Dry eye | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye discharge | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye irritation | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Vision blurred | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Vitreous detachment | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Blepharitis | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Chalazion | 2 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Conjunctival papillae | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Corneal oedema | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Erythema of eyelid | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Lacrimation increased | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Ocular hyperaemia | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Optic nerve cupping | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Eye pain | 2 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Hordeolum | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Swelling of eyelid | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: General disorders and administration site conditions | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Instillation site irritation | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Instillation site pruritus | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Therapy responder | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Immune system disorders | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Drug hypersensitivity | 0 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | SOC: Injury, poisoning and procedural complications | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Corneal abrasion | 1 Participants |
| SAF312 Placebo | Ocular Treatment Emergent Adverse Events, by Primary System Organ Class (SOC) and Preferred Term (PT) | -Foreign body in eye | 1 Participants |
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.
Time frame: 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).
Population: Safety set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAF312 15 mg/mL | Summary of Non-ocular Treatment Emergent Adverse Events | 13 Participants |
| SAF312 5mg/mL | Summary of Non-ocular Treatment Emergent Adverse Events | 4 Participants |
| SAF312 Placebo | Summary of Non-ocular Treatment Emergent Adverse Events | 13 Participants |