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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1-4: SJP-0132 | Experimental | Each cohort will receive a single dose of 1 of 4 strengths of SJP-0132 |
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| Cohort 1-4: Placebo | Placebo Comparator | Single dose of placebo |
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| Cohort 5-6: SJP-0132 | Experimental | Cohort 5 SJP-0132 will receive the second maximum acceptable dose from Cohorts 1-4 for 4 weeks. Cohort 6 SJP-0132 will receive the maximum acceptable dose from Cohorts 1-4 for 4 weeks |
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| Cohort 5-6: Placebo | Placebo Comparator | Multiple dose placebo for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJP-0132 | Drug | SJP-0132 is administered as an eye drop |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 2 for cohort 1-4, Day 29 for cohort 5-6 |
| 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. | Day 2 for cohort 1-4, Day 29 for cohort 5-6 |
| 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. | Day 1 |
| 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. | Day 1 |
| Accumulation Ratio (Rac) After Multiple Dosing |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 29 |
| Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Senju Investigational Site | Cypress | California | 90630 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-dose (Cohort 1): 0.03% SJP-0132 | Single dose of 0.03% SJP-0132 as Cohort 1 |
| FG001 | Single-dose (Cohort 2) : 0.1% SJP-0132 | Single dose of 0.1% SJP-0132 as Cohort 2 |
| FG002 | Single-dose (Cohort 3) : 0.3% SJP-0132 | Single dose of 0.3% SJP-0132 as Cohort 3 |
| FG003 | Single-dose (Cohort 4) : 1% SJP-0132 | Single dose of 1% SJP-0132 as Cohort 4 |
| FG004 | Single-dose (Cohort 1-4) : Placebo | Single dose of placebo as Cohort 1 to 4 |
| FG005 | Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5 |
| FG006 | Multiple-dose (Cohort 6) : 1% SJP-0132 | Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6 |
| FG007 | Multiple-dose (Cohort 5, 6) : Placebo | Multiple dose for 4 weeks as Cohort 5 and 6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-dose (Cohort 1) : 0.03% SJP-0132 | Single dose of 0.03% SJP-0132 as Cohort 1 |
| BG001 | Single-dose (Cohort 2) : 0.1% SJP-0132 | Single dose of 0.1% SJP-0132 as Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety set | Posted | Count of Participants | Participants | Day 2 for cohort 1-4, Day 29 for cohort 5-6 |
|
Day 2 for cohort 1-4, Day 29 for cohort 5-6
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-dose (Cohort 1) : SJP-0132 Low Dose | Single dose of Low strength of SJP-0132 as Cohort 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
All of the efficacy and safety measurements applied in this study are widely used and generally recognized as reliable, accurate, and relevant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Development | Senju Pharmaceutical Co. Ltd. | +81 078 777 1018 | senju-clinicaltrials@senju.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2019 | Mar 29, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo | Drug | Placebo is administered as an eye drop |
|
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) |
| Day 2, 4, 8 |
| 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. | Day 29 |
| 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. | Day 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. |
| Day 8, 15, 22, 29 |
| 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. | Day 8, 15, 22, 29 |
| 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. | Day 8, 15, 22, 29 |
| 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. | Day 8, 15, 22, 29 |
| 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). | Day 8, 15, 22, 29 |
| 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. | Day 29 |
| 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. | Day 29 |
| BG002 | Single-dose (Cohort 3) : 0.3% SJP-0132 | Single dose of 0.3% SJP-0132 as Cohort 3 |
| BG003 | Single-dose (Cohort 4) : 1% SJP-0132 | Single dose of 1% SJP-0132 as Cohort 4 |
| BG004 | Single-dose (Cohort 1-4) : Placebo | Single dose of placebo as Cohort 1 to 4 |
| BG005 | Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5 |
| BG006 | Multiple-dose (Cohort 6) : 1% SJP-0132 | Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6 |
| BG007 | Multiple-dose (Cohort 5, 6) : Placebo | Multiple dose for 4 weeks as Cohort 5 and 6 |
| BG008 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | Kg/m^2 |
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Single dose of 0.1% SJP-0132 as Cohort 2
| OG002 | Single-dose (Cohort 3) : 0.3% SJP-0132 | Single dose of 0.3% SJP-0132 as Cohort 3 |
| OG003 | Single-dose (Cohort 4) : 1% SJP-0132 | Single dose of 1% SJP-0132 as Cohort 4 |
| OG004 | Single-dose (Cohort 1-4) : Placebo | Single dose of placebo as Cohort 1 to 4 |
| OG005 | Multiple-dose (Cohort 5) : 0.3% SJP-0132 | Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5 |
| OG006 | Multiple-dose (Cohort 6) : 1% SJP-0132 | Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6 |
| OG007 | Multiple-dose (Cohort 5, 6) : Placebo | Multiple dose of placebo for 4 weeks as Cohort 5 and 6 |
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| 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. | Safety Set | Posted | Count of Participants | Participants | Day 2 for cohort 1-4, Day 29 for cohort 5-6 |
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| 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. | Pharmacokinetic Set | Posted | Mean | Standard Deviation | ng/mL | Day 1 |
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| 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. | Pharmacokinetic Set | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1 |
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| 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) | Pharmacokinetic Set | Posted | Mean | Standard Deviation | Ratio | Day 2, 4, 8 |
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| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 29 |
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| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale | Day 29 | Study eye | Study eye |
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| 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. | Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Day 29 |
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| 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. | Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Day 8, 15, 22, 29 | Study eye | Study eye |
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| 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. | Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Day 8, 15, 22, 29 | Study eye | Study eye |
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| 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. | Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Day 8, 15, 22, 29 | Study eye | Study eye |
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| 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. | Full Analysis Set. One participant in placebo group was not completed the study. | Posted | Mean | Standard Deviation | sec | Day 8, 15, 22, 29 | Study eye | Study eye |
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| 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). | Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Day 8, 15, 22, 29 |
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| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale | Day 29 |
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| 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. | Full Analysis Set | Posted | Count of Units | Study eye | Day 29 | Study eye | Study eye |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Single-dose (Cohort 2) : SJP-0132 Mid-Low Dose | Single dose of Mid-Low strength of SJP-0132 as Cohort 2 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Single-dose (Cohort 3) : SJP-0132 Mid-High Dose | Single dose of Mid-High strength of SJP-0132 as Cohort 3 | 0 | 5 | 0 | 5 | 2 | 5 |
| EG003 | Single-dose (Cohort 4) : SJP-0132 High Dose | Single dose of High strength of SJP-0132 as Cohort 4 | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Single-dose (Cohort 1-4) : Placebo | Single dose of placebo as Cohort 1 to 4 | 0 | 8 | 0 | 8 | 0 | 8 |
| EG005 | Multiple-dose (Cohort 5) : SJP-0132 Mid-High Dose | Multiple dose of Mid-High strength of SJP-0132 for 4 weeks as Cohort 5 | 0 | 20 | 0 | 20 | 1 | 20 |
| EG006 | Multiple-dose (Cohort 6) : SJP-0132 High Dose | Multiple dose of High strength of SJP-0132 for 4 weeks as Cohort 6 | 0 | 20 | 0 | 20 | 5 | 20 |
| EG007 | Multiple-dose (Cohort 5, 6) : Placebo | Multiple dose of placebo for 4 weeks as Cohort 5 and 6 | 0 | 20 | 0 | 20 | 7 | 20 |
| Conjunctival hemorrhage | Eye disorders | MedDRA 22.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Sensitive skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Ophthalmologic observations |
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