Dry Eye Disease, Dry Eye Syndrome
Conditions
Brief summary
This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease
Interventions
DRUGSJP-0132
SJP-0132 is administered as an eye drop
DRUGPlacebo
Placebo is administered as an eye drop
Sponsors
Senju Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) within 18.5 to 30.0 kg/m2 (inclusive) and body weight between 45 kg and 100 kg * Generally healthy as determined by medical history, physical examinations, clinical laboratory examination, and ophthalmologic examinations performed at Screening * Have a subject reported history of Dry Eye Disease in both eyes for at least 6 months prior to Screening * Non-smoker or ex-smoker for \>12 months
Exclusion criteria
* Have clinically significant systemic or ophthalmic disease * Has a positive serum pregnancy test at Screening or urine pregnancy test * Have had significant blood loss or have donated or received one or more units (450 mL) of blood or plasma within 30 days before randomization * Have used or anticipates use of any prescription or over-the-counter medication, including topical medications such as ophthalmic solutions, nasal drops or spray, vitamins, alternative and complementary medicines (including herbal formulations) within 14 days or 5 half-lives (whichever is longer) before randomization or at any time during the study * Use or anticipates use of prescribed dry eye medications within 28 days prior to randomization or at any time during the study * Have used or anticipates use CYP3A4 inducers, such as St. John's Wort, within 14 days before randomization or at any time during the study. * Have consumed red wine, grapefruit or grapefruit juice, Seville oranges, star fruit, or any products containing these items, or any foods that may inhibit CYP3A4, within 48 hours before randomization and throughout the duration of the study * Have a positive urine alcohol or urine drug test at Screening or Day -1 * Contact lens wearers who cannot discontinue the wear over the trial period * Have undergone eye surgery (including laser surgery) within the last 12 months or whom the Investigator considers unsuitable * Have a best corrected visual acuity (BCVA) worse than 20/100 in either eye * History of permanent punctal occlusion (cautery or laser) or current use of punctal plugs * Any corneal abnormality or disease which might impact normal tear film spreading * Active or history of significant corneal disease * Known allergy or sensitivity to fluorescein, lissamine green or any of the study medications Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events by Severity in Each Cohort | Day 2 for cohort 1-4, Day 29 for cohort 5-6 | Number of participants with adverse events by severity are summarize in each cohort. Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug. |
| Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Day 2 for cohort 1-4, Day 29 for cohort 5-6 | Clinical laboratory parameters include hematology, clinical chemistry, urinalysis, and serology. Vital signs include diastolic blood pressure, systolic blood pressure, heart rate, respiratory rate, and body temperature. Ophthalmologic observations include examination of visual acuity, slit lamp biomicroscopy, Schirmer I, intraocular pressure, and ophthalmoscopy. |
| Maximum Plasma Concentration (Cmax) | Day 1 | The results are from the maximum plasma concentration (Cmax) on Day 1. The blood for pharmacokinetics assessment was collected at 0, 0.25, 0.5, 1, 2, 4, 8, and 12 hours after dosing on Day 1 for Cohorts 1 to 4. The blood for pharmacokinetics assessment was collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1 for Cohorts 5 and 6. |
| Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) | Day 1 | Area under the plasma concentration-time curves (AUCs) for Cohorts 1 to 4 were calculated using the plasma collected at 0, 0.25, 0.5, 1, 2, 4, 8, and 12 hours after dosing on Day 1, and those for Cohorts 5 and 6 were calculated using the plasma collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1. |
| Accumulation Ratio (Rac) After Multiple Dosing | Day 2, 4, 8 | Plasma were collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1, pre-dose on Day 2, Day 4 and Day 8. Accumulation ratios calculated as (predose plasma concentration \[Ctrough\] on Day 4) / (Ctrough on Day 2) and (Ctrough on Day 8) / (Ctrough on Day 2) |
| Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29 | Day 29 | Visual analog scale (VAS): 0 mean none, and 100 mean the worst imaginable for the symptom question. |
| Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29 | Day 29 | Change from baseline of central zone CFS score at the central zone on Day 29. CFS score at the central zone ranged from 0 to 5, where '0' represents no fluorescein staining, and '5' represents severe staining on the cornea. The higher scores mean worse outcomes. Results from the study eye are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 29 | Visual analog scale (VAS): 0 mean none, and 100 mean the worst imaginable for the symptom question. Results from pre-dose are reported. |
| Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Levels of the inflammatory marker Matrix Metalloproteinase-9 (MMP-9) were measured in each eye using InflammaDry. The test was recorded as either positive or negative. Results from the study eye are reported. |
| Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 8, 15, 22, 29 | Change from baseline of CFS score at the total zone of pre-dose in each time point. Total zone means a summary of central, superior, inferior, nasal, and temporal zones. The range of the score in each zone is 0 to 5 points, and the total score is 25 points. The higher scores mean worse outcomes. |
| Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 8, 15, 22, 29 | The score in each zone is 0 to 5 points, and the maximum total score is 30 points. The higher scores mean worse outcomes. Results from the study eye are reported. |
| Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 8, 15, 22, 29 | Lissamine green staining of the lid wiper was graded from 0 to 3. The higher scores mean worse outcomes. Results from the study eye are reported. |
| Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 8, 15, 22, 29 | Tear film break-up time is the time taken for the first dry spot to appear on the cornea after a complete blink. |
| Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 8, 15, 22, 29 | The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The participant was asked to rate each question using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: (\[sum of scores for all questions answered\] X 25)/(\[total number of questions answered\]). The OSDI can range from 0 (normal) to 100 (abnormal). |
| Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores | Day 29 | The participants rated the frequency on a scale of 0 (never) to 4 (constant) with which they have experienced 3 symptoms (watery eyes, discomfort and dryness). The participant was also asked to rate the intensity of discomfort and dryness on a scale of 0 (never have it) to 5 (very intense). Total DEQ-5 score was the sum of scores for frequency and intensity of dryness and discomfort plus frequency of watery eyes. Maximum score is 22. Higher scores mean a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 Single dose of 0.03% SJP-0132 as Cohort 1 | 6 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 Single dose of 0.1% SJP-0132 as Cohort 2 | 6 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 Single dose of 0.3% SJP-0132 as Cohort 3 | 5 |
| Single-dose (Cohort 4) : 1% SJP-0132 Single dose of 1% SJP-0132 as Cohort 4 | 4 |
| Single-dose (Cohort 1-4) : Placebo Single dose of placebo as Cohort 1 to 4 | 8 |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5 | 20 |
| Multiple-dose (Cohort 6) : 1% SJP-0132 Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6 | 20 |
| Multiple-dose (Cohort 5, 6) : Placebo Multiple dose for 4 weeks as Cohort 5 and 6 | 20 |
| Total | 89 |
Baseline characteristics
| Characteristic | Single-dose (Cohort 1) : 0.03% SJP-0132 | Single-dose (Cohort 2) : 0.1% SJP-0132 | Single-dose (Cohort 3) : 0.3% SJP-0132 | Single-dose (Cohort 4) : 1% SJP-0132 | Single-dose (Cohort 1-4) : Placebo | Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Multiple-dose (Cohort 6) : 1% SJP-0132 | Multiple-dose (Cohort 5, 6) : Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 27.8 years STANDARD_DEVIATION 5.64 | 34.8 years STANDARD_DEVIATION 7.78 | 35.0 years STANDARD_DEVIATION 6.82 | 35.8 years STANDARD_DEVIATION 11.87 | 33.0 years STANDARD_DEVIATION 6.72 | 46.1 years STANDARD_DEVIATION 14.34 | 34.9 years STANDARD_DEVIATION 8.07 | 39.7 years STANDARD_DEVIATION 11.74 | 37.9 years STANDARD_DEVIATION 11.51 |
| BMI | 24.675 Kg/m^2 STANDARD_DEVIATION 3.8471 | 23.882 Kg/m^2 STANDARD_DEVIATION 4.0167 | 24.144 Kg/m^2 STANDARD_DEVIATION 3.6329 | 24.593 Kg/m^2 STANDARD_DEVIATION 3.5238 | 23.303 Kg/m^2 STANDARD_DEVIATION 3.1095 | 23.596 Kg/m^2 STANDARD_DEVIATION 2.967 | 25.513 Kg/m^2 STANDARD_DEVIATION 2.9228 | 24.407 Kg/m^2 STANDARD_DEVIATION 2.7066 | 24.35 Kg/m^2 STANDARD_DEVIATION 3.0727 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 14 Participants | 12 Participants | 10 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 6 Participants | 8 Participants | 10 Participants | 36 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 5 participants | 4 participants | 8 participants | 20 participants | 20 participants | 20 participants | 89 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 3 Participants | 0 Participants | 6 Participants | 13 Participants | 8 Participants | 13 Participants | 50 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 7 Participants | 12 Participants | 7 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 4 | 0 / 8 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 2 / 5 | 0 / 4 | 0 / 8 | 1 / 20 | 5 / 20 | 7 / 20 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 4 | 0 / 8 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Accumulation Ratio (Rac) After Multiple Dosing
Plasma were collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1, pre-dose on Day 2, Day 4 and Day 8. Accumulation ratios calculated as (predose plasma concentration \[Ctrough\] on Day 4) / (Ctrough on Day 2) and (Ctrough on Day 8) / (Ctrough on Day 2)
Time frame: Day 2, 4, 8
Population: Pharmacokinetic Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Accumulation Ratio (Rac) After Multiple Dosing | Rac Day 4/Day 2 | 1.75758 Ratio | Standard Deviation 0.705735 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Accumulation Ratio (Rac) After Multiple Dosing | Rac Day 8/Day 2 | 2.84759 Ratio | Standard Deviation 1.858905 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Accumulation Ratio (Rac) After Multiple Dosing | Rac Day 4/Day 2 | 1.67083 Ratio | Standard Deviation 0.812324 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Accumulation Ratio (Rac) After Multiple Dosing | Rac Day 8/Day 2 | 2.79157 Ratio | Standard Deviation 1.676501 |
Primary
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last)
Area under the plasma concentration-time curves (AUCs) for Cohorts 1 to 4 were calculated using the plasma collected at 0, 0.25, 0.5, 1, 2, 4, 8, and 12 hours after dosing on Day 1, and those for Cohorts 5 and 6 were calculated using the plasma collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1.
Time frame: Day 1
Population: Pharmacokinetic Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) | 0.28671 hr*ng/mL | Standard Deviation 0.158116 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) | 1.02449 hr*ng/mL | Standard Deviation 0.827814 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) | 0.85442 hr*ng/mL | Standard Deviation 0.462688 |
| Single-dose (Cohort 4) : 1% SJP-0132 | Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) | 5.15571 hr*ng/mL | Standard Deviation 2.537673 |
| Single-dose (Cohort 1-4) : Placebo | Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) | 0.32305 hr*ng/mL | Standard Deviation 0.178608 |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) | 1.14604 hr*ng/mL | Standard Deviation 1.02445 |
Primary
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29
Change from baseline of central zone CFS score at the central zone on Day 29. CFS score at the central zone ranged from 0 to 5, where '0' represents no fluorescein staining, and '5' represents severe staining on the cornea. The higher scores mean worse outcomes. Results from the study eye are reported.
Time frame: Day 29
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29 | -1.1 score on a scale | Standard Deviation 1.19 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29 | -1.3 score on a scale | Standard Deviation 1.08 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29 | -1.2 score on a scale | Standard Deviation 1.36 |
Primary
Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29
Visual analog scale (VAS): 0 mean none, and 100 mean the worst imaginable for the symptom question.
Time frame: Day 29
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29 | -34.2 units on a scale | Standard Deviation 21.97 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29 | -26.3 units on a scale | Standard Deviation 22 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29 | -29.8 units on a scale | Standard Deviation 30.13 |
Primary
Maximum Plasma Concentration (Cmax)
The results are from the maximum plasma concentration (Cmax) on Day 1. The blood for pharmacokinetics assessment was collected at 0, 0.25, 0.5, 1, 2, 4, 8, and 12 hours after dosing on Day 1 for Cohorts 1 to 4. The blood for pharmacokinetics assessment was collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1 for Cohorts 5 and 6.
Time frame: Day 1
Population: Pharmacokinetic Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Maximum Plasma Concentration (Cmax) | 0.03773 ng/mL | Standard Deviation 0.015911 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Maximum Plasma Concentration (Cmax) | 0.12940 ng/mL | Standard Deviation 0.095403 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Maximum Plasma Concentration (Cmax) | 0.10228 ng/mL | Standard Deviation 0.063893 |
| Single-dose (Cohort 4) : 1% SJP-0132 | Maximum Plasma Concentration (Cmax) | 0.69275 ng/mL | Standard Deviation 0.293932 |
| Single-dose (Cohort 1-4) : Placebo | Maximum Plasma Concentration (Cmax) | 0.14077 ng/mL | Standard Deviation 0.106705 |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Maximum Plasma Concentration (Cmax) | 0.63273 ng/mL | Standard Deviation 0.804411 |
Primary
Number of Participants With Adverse Events by Severity in Each Cohort
Number of participants with adverse events by severity are summarize in each cohort. Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
Time frame: Day 2 for cohort 1-4, Day 29 for cohort 5-6
Population: Safety set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Severe | 0 Participants |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Mild | 0 Participants |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Moderate | 0 Participants |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Mild | 0 Participants |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Severe | 0 Participants |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Moderate | 0 Participants |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Severe | 0 Participants |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Mild | 2 Participants |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Moderate | 0 Participants |
| Single-dose (Cohort 4) : 1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Mild | 0 Participants |
| Single-dose (Cohort 4) : 1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Moderate | 0 Participants |
| Single-dose (Cohort 4) : 1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Severe | 0 Participants |
| Single-dose (Cohort 1-4) : Placebo | Number of Participants With Adverse Events by Severity in Each Cohort | Moderate | 0 Participants |
| Single-dose (Cohort 1-4) : Placebo | Number of Participants With Adverse Events by Severity in Each Cohort | Mild | 0 Participants |
| Single-dose (Cohort 1-4) : Placebo | Number of Participants With Adverse Events by Severity in Each Cohort | Severe | 0 Participants |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Moderate | 0 Participants |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Mild | 1 Participants |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Severe | 0 Participants |
| Multiple-dose (Cohort 6) : 1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Moderate | 0 Participants |
| Multiple-dose (Cohort 6) : 1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Mild | 5 Participants |
| Multiple-dose (Cohort 6) : 1% SJP-0132 | Number of Participants With Adverse Events by Severity in Each Cohort | Severe | 0 Participants |
| Multiple-dose (Cohort 5, 6) : Placebo | Number of Participants With Adverse Events by Severity in Each Cohort | Mild | 7 Participants |
| Multiple-dose (Cohort 5, 6) : Placebo | Number of Participants With Adverse Events by Severity in Each Cohort | Moderate | 0 Participants |
| Multiple-dose (Cohort 5, 6) : Placebo | Number of Participants With Adverse Events by Severity in Each Cohort | Severe | 0 Participants |
Primary
Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort
Clinical laboratory parameters include hematology, clinical chemistry, urinalysis, and serology. Vital signs include diastolic blood pressure, systolic blood pressure, heart rate, respiratory rate, and body temperature. Ophthalmologic observations include examination of visual acuity, slit lamp biomicroscopy, Schirmer I, intraocular pressure, and ophthalmoscopy.
Time frame: Day 2 for cohort 1-4, Day 29 for cohort 5-6
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Laboratory parameters | 0 Participants |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Vital signs | 0 Participants |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Physical observations | 0 Participants |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Ophthalmologic observations | 0 Participants |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Ophthalmologic observations | 0 Participants |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Vital signs | 0 Participants |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Laboratory parameters | 0 Participants |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Physical observations | 0 Participants |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Laboratory parameters | 0 Participants |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Ophthalmologic observations | 0 Participants |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Vital signs | 0 Participants |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Physical observations | 1 Participants |
| Single-dose (Cohort 4) : 1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Laboratory parameters | 0 Participants |
| Single-dose (Cohort 4) : 1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Vital signs | 0 Participants |
| Single-dose (Cohort 4) : 1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Physical observations | 0 Participants |
| Single-dose (Cohort 4) : 1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Ophthalmologic observations | 0 Participants |
| Single-dose (Cohort 1-4) : Placebo | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Ophthalmologic observations | 0 Participants |
| Single-dose (Cohort 1-4) : Placebo | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Physical observations | 0 Participants |
| Single-dose (Cohort 1-4) : Placebo | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Vital signs | 0 Participants |
| Single-dose (Cohort 1-4) : Placebo | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Laboratory parameters | 0 Participants |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Ophthalmologic observations | 0 Participants |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Physical observations | 0 Participants |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Vital signs | 0 Participants |
| Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Laboratory parameters | 0 Participants |
| Multiple-dose (Cohort 6) : 1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Ophthalmologic observations | 0 Participants |
| Multiple-dose (Cohort 6) : 1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Laboratory parameters | 0 Participants |
| Multiple-dose (Cohort 6) : 1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Physical observations | 2 Participants |
| Multiple-dose (Cohort 6) : 1% SJP-0132 | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Vital signs | 0 Participants |
| Multiple-dose (Cohort 5, 6) : Placebo | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Vital signs | 0 Participants |
| Multiple-dose (Cohort 5, 6) : Placebo | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Physical observations | 4 Participants |
| Multiple-dose (Cohort 5, 6) : Placebo | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Ophthalmologic observations | 0 Participants |
| Multiple-dose (Cohort 5, 6) : Placebo | Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort | Laboratory parameters | 0 Participants |
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints
The score in each zone is 0 to 5 points, and the maximum total score is 30 points. The higher scores mean worse outcomes. Results from the study eye are reported.
Time frame: Day 8, 15, 22, 29
Population: Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 8 | 0.6 score on a scale | Standard Deviation 5.25 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 15 | 0.5 score on a scale | Standard Deviation 5.66 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 22 | 0.5 score on a scale | Standard Deviation 4.97 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 29 | 0.5 score on a scale | Standard Deviation 5.95 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 29 | 1.4 score on a scale | Standard Deviation 5.43 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 8 | 1.7 score on a scale | Standard Deviation 5.28 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 22 | 1.9 score on a scale | Standard Deviation 4.15 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 15 | 2.1 score on a scale | Standard Deviation 5.35 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 29 | 2.3 score on a scale | Standard Deviation 4.26 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 15 | 1.6 score on a scale | Standard Deviation 3.93 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 22 | 1.8 score on a scale | Standard Deviation 4.44 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints | Day 8 | 0.3 score on a scale | Standard Deviation 3.8 |
Secondary
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints
Change from baseline of CFS score at the total zone of pre-dose in each time point. Total zone means a summary of central, superior, inferior, nasal, and temporal zones. The range of the score in each zone is 0 to 5 points, and the total score is 25 points. The higher scores mean worse outcomes.
Time frame: Day 8, 15, 22, 29
Population: Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 8 | -1.9 score on a scale | Standard Deviation 4.84 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 15 | -3.9 score on a scale | Standard Deviation 3.92 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 22 | -4.4 score on a scale | Standard Deviation 3.5 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 29 | -3.4 score on a scale | Standard Deviation 3.82 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 29 | -1.8 score on a scale | Standard Deviation 5.15 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 8 | 0.6 score on a scale | Standard Deviation 2.74 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 22 | 0.2 score on a scale | Standard Deviation 5.16 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 15 | -0.2 score on a scale | Standard Deviation 4.76 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 29 | -1.8 score on a scale | Standard Deviation 4.94 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 15 | -2.3 score on a scale | Standard Deviation 5.7 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 22 | -1.4 score on a scale | Standard Deviation 3.85 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints | Day 8 | -0.6 score on a scale | Standard Deviation 2.96 |
Secondary
Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores
The participants rated the frequency on a scale of 0 (never) to 4 (constant) with which they have experienced 3 symptoms (watery eyes, discomfort and dryness). The participant was also asked to rate the intensity of discomfort and dryness on a scale of 0 (never have it) to 5 (very intense). Total DEQ-5 score was the sum of scores for frequency and intensity of dryness and discomfort plus frequency of watery eyes. Maximum score is 22. Higher scores mean a worse outcome.
Time frame: Day 29
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores | -6.0 score on a scale | Standard Deviation 3.46 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores | -4.9 score on a scale | Standard Deviation 4 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores | -3.6 score on a scale | Standard Deviation 3.59 |
Secondary
Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints
Visual analog scale (VAS): 0 mean none, and 100 mean the worst imaginable for the symptom question. Results from pre-dose are reported.
Time frame: Day 29
Population: Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 22 | -30.3 score on a scale | Standard Deviation 23.47 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 8 | -29.7 score on a scale | Standard Deviation 24.08 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 29 | -34.6 score on a scale | Standard Deviation 22.27 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 2 | -14.3 score on a scale | Standard Deviation 17.82 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 15 | -30.1 score on a scale | Standard Deviation 21.44 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 2 | -12.1 score on a scale | Standard Deviation 17.92 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 22 | -21.9 score on a scale | Standard Deviation 22.21 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 15 | -17.6 score on a scale | Standard Deviation 21.03 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 29 | -23.9 score on a scale | Standard Deviation 22.46 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 8 | -22.3 score on a scale | Standard Deviation 21.33 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 29 | -26.8 score on a scale | Standard Deviation 30.28 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 8 | -24.2 score on a scale | Standard Deviation 27.03 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 15 | -22.8 score on a scale | Standard Deviation 24.12 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 22 | -28.9 score on a scale | Standard Deviation 29.71 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints | Day 2 | -8.0 score on a scale | Standard Deviation 14.74 |
Secondary
Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints
Lissamine green staining of the lid wiper was graded from 0 to 3. The higher scores mean worse outcomes. Results from the study eye are reported.
Time frame: Day 8, 15, 22, 29
Population: Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 8 | -0.10 score on a scale | Standard Deviation 0.62 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 15 | 0.08 score on a scale | Standard Deviation 0.799 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 22 | -0.13 score on a scale | Standard Deviation 0.496 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 29 | -0.70 score on a scale | Standard Deviation 1.081 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 29 | -0.43 score on a scale | Standard Deviation 0.73 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 8 | -0.33 score on a scale | Standard Deviation 0.52 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 22 | -0.35 score on a scale | Standard Deviation 0.63 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 15 | -0.40 score on a scale | Standard Deviation 0.641 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 29 | -0.53 score on a scale | Standard Deviation 0.993 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 15 | -0.33 score on a scale | Standard Deviation 0.963 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 22 | -0.18 score on a scale | Standard Deviation 0.989 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints | Day 8 | -0.50 score on a scale | Standard Deviation 0.973 |
Secondary
Change From Baseline in Ocular Surface Disease Index (OSDI)
The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The participant was asked to rate each question using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: (\[sum of scores for all questions answered\] X 25)/(\[total number of questions answered\]). The OSDI can range from 0 (normal) to 100 (abnormal).
Time frame: Day 8, 15, 22, 29
Population: Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 8 | -24.19 score on a scale | Standard Deviation 22.037 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 15 | -22.94 score on a scale | Standard Deviation 22.554 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 22 | -24.02 score on a scale | Standard Deviation 22.182 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 29 | -24.38 score on a scale | Standard Deviation 21.891 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 29 | -9.30 score on a scale | Standard Deviation 22.785 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 8 | -9.67 score on a scale | Standard Deviation 19.494 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 22 | -9.04 score on a scale | Standard Deviation 20.266 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 15 | -9.94 score on a scale | Standard Deviation 20.342 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 29 | -23.54 score on a scale | Standard Deviation 23.508 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 15 | -23.91 score on a scale | Standard Deviation 17.298 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 22 | -22.21 score on a scale | Standard Deviation 20.1 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 8 | -28.17 score on a scale | Standard Deviation 18.536 |
Secondary
Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints
Tear film break-up time is the time taken for the first dry spot to appear on the cornea after a complete blink.
Time frame: Day 8, 15, 22, 29
Population: Full Analysis Set. One participant in placebo group was not completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 15 | 1.26 sec | Standard Deviation 2.848 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 22 | 0.98 sec | Standard Deviation 2.56 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 8 | 0.54 sec | Standard Deviation 2.58 |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 29 | 1.29 sec | Standard Deviation 3.435 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 15 | 0 sec | Standard Deviation 1.789 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 8 | -0.04 sec | Standard Deviation 1.834 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 22 | -0.29 sec | Standard Deviation 1.178 |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 29 | 0.32 sec | Standard Deviation 2.147 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 22 | 0.89 sec | Standard Deviation 2.212 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 8 | 0.52 sec | Standard Deviation 2.024 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 15 | -0.08 sec | Standard Deviation 2.755 |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints | Day 29 | 0.66 sec | Standard Deviation 1.72 |
Secondary
Change in Matrix Metalloproteinase-9 (MMP-9)
Levels of the inflammatory marker Matrix Metalloproteinase-9 (MMP-9) were measured in each eye using InflammaDry. The test was recorded as either positive or negative. Results from the study eye are reported.
Time frame: Day 29
Population: Full Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Missing | 0 Study eye |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Missing | 0 Study eye |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Negative | 18 Study eye |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Positive | 14 Study eye |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Positive | 2 Study eye |
| Single-dose (Cohort 1) : 0.03% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Negative | 6 Study eye |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Positive | 4 Study eye |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Negative | 16 Study eye |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Negative | 18 Study eye |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Missing | 0 Study eye |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Positive | 2 Study eye |
| Single-dose (Cohort 2) : 0.1% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Missing | 0 Study eye |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Missing | 1 Study eye |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Positive | 8 Study eye |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Negative | 12 Study eye |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Baseline | Missing | 0 Study eye |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Positive | 7 Study eye |
| Single-dose (Cohort 3) : 0.3% SJP-0132 | Change in Matrix Metalloproteinase-9 (MMP-9) | Day 29 | Negative | 12 Study eye |