Dry Eye DiseasePhase 1/2NCT04139122

Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease

A Phase 1/2 study testing SJP-0132 in people with Dry Eye Disease and Dry Eye Syndrome, run by Senju Pharmaceutical Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Disease, Dry Eye Syndrome
What is being tested?: SJP-0132
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2019to 3 Mar 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 16Show fewer

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/Exclusion Criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Senju Investigational Site
Cypress, California, 90630

Other trials in United States

About this study

Official title: A Randomized, Double-Masked, Single-Center, Placebo-Controlled Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of SJP-0132 in Subjects With Dry Eye Disease

Conditions: Dry Eye Disease, Dry Eye Syndrome
Being tested: SJP-0132, Placebo
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SJP-0132Drug
SJP-0132 is administered as an eye drop
PlaceboDrug
Placebo is administered as an eye drop

Study groups in NCT04139122
Study group	Role	What they receive
Cohort 1-4: SJP-0132	Experimental	Each cohort will receive a single dose of 1 of 4 strengths of SJP-0132 Receives: Drug: SJP-0132
Cohort 1-4: Placebo	Placebo comparator	Single dose of placebo Receives: Drug: Placebo
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 Receives: Drug: SJP-0132
Cohort 5-6: Placebo	Placebo comparator	Multiple dose placebo for 4 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
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)
Measured: 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.
Measured: 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.
Measured: Day 29

Secondary outcomes (8)

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.
Measured: Day 29
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 20193 Mar 2020

First posted25 Oct 2019
Study start5 Oct 2019
Primary completion3 Mar 2020
Study completion3 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04139122
Sponsor's protocol ID: SJP-0132/1-01
Status last verified: Mar 2023
First submitted: 14 Oct 2019
Last updated: 20 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Masked, Single-Center, Placebo-Controlled Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of SJP-0132 in Subjects With Dry Eye Disease
ClinicalTrials.gov ID: NCT04139122
Acronym / sponsor ID: SJP-0132/1-01
Conditions: Dry Eye Disease, Dry Eye Syndrome
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Senju Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 5 Oct 2019 (actual)
Primary completion: 3 Mar 2020 (actual)
Study completion: 3 Mar 2020 (actual)
First posted: 25 Oct 2019 (actual)
Results: Posted 20 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Cohort 1-4: SJP-0132	Experimental	Drug: SJP-0132Each cohort will receive a single dose of 1 of 4 strengths of SJP-0132
Cohort 1-4: Placebo	Placebo comparator	Drug: PlaceboSingle dose of placebo
Cohort 5-6: SJP-0132	Experimental	Drug: SJP-0132Cohort 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
Cohort 5-6: Placebo	Placebo comparator	Drug: PlaceboMultiple dose placebo for 4 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SJP-0132SJP-0132 is administered as an eye drop	Drug	Cohort 1-4: SJP-0132, Cohort 5-6: SJP-0132
PlaceboPlacebo is administered as an eye drop	Drug	Cohort 1-4: Placebo, Cohort 5-6: Placebo

Primary outcome

Number of Participants With Adverse Events by Severity in Each Cohort
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

8 secondary outcomes

Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints
Time frame: Day 29
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints
Time frame: Day 8, 15, 22, 29
Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints
Time frame: Day 8, 15, 22, 29
Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints
Time frame: Day 8, 15, 22, 29
Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints
Time frame: Day 8, 15, 22, 29
Change From Baseline in Ocular Surface Disease Index (OSDI)
Time frame: Day 8, 15, 22, 29
Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores
Time frame: Day 29
Change in Matrix Metalloproteinase-9 (MMP-9)
Time frame: Day 29

Results and safety

Results posted to the registry on 20 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-dose (Cohort 1): 0.03% SJP-0132	6	5
Single-dose (Cohort 2) : 0.1% SJP-0132	6	6
Single-dose (Cohort 3) : 0.3% SJP-0132	5	5
Single-dose (Cohort 4) : 1% SJP-0132	4	4
Single-dose (Cohort 1-4) : Placebo	8	8
Multiple-dose (Cohort 5) : 0.3% SJP-0132	20	20
Multiple-dose (Cohort 6) : 1% SJP-0132	20	20
Multiple-dose (Cohort 5, 6) : Placebo	20	19

Primary outcome: Number of Participants With Adverse Events by Severity in Each Cohort

Time frame: Day 2 for cohort 1-4, Day 29 for cohort 5-6. Count of participants. Unit: Participants

Measure	Single-dose (Cohort 3) : 0.3% SJP-0132 n = 5	Multiple-dose (Cohort 5) : 0.3% SJP-0132 n = 20	Multiple-dose (Cohort 6) : 1% SJP-0132 n = 20	Multiple-dose (Cohort 5, 6) : Placebo n = 20
Mild	2	1	5	7
Moderate	0	0	0	0
Severe	0	0	0	0

Population analysed: Safety set

Primary outcome: Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort

Time frame: Day 2 for cohort 1-4, Day 29 for cohort 5-6. Count of participants. Unit: Participants

Measure	Single-dose (Cohort 3) : 0.3% SJP-0132 n = 5	Multiple-dose (Cohort 6) : 1% SJP-0132 n = 20	Multiple-dose (Cohort 5, 6) : Placebo n = 20
Laboratory parameters	0	0	0
Vital signs	0	0	0
Physical observations	1	2	4
Ophthalmologic observations	0	0	0

Population analysed: Safety Set

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: Day 1. Mean (Standard Deviation). Unit: ng/mL

Measure	Single-dose (Cohort 1):0.03% SJP-0132 n = 6	Single-dose (Cohort 2):0.1% SJP-0132 n = 6	Single-dose (Cohort 3):0.3% SJP-0132 n = 5	Single-dose (Cohort 4):1% SJP-0132 n = 4	Multiple-dose (Cohort 5):0.3% SJP-0132 n = 12	Multiple-dose (Cohort 6):1% SJP-0132 n = 12
Value	0.03773 (0.015911)	0.12940 (0.095403)	0.10228 (0.063893)	0.69275 (0.293932)	0.14077 (0.106705)	0.63273 (0.804411)

Population analysed: Pharmacokinetic Set

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last)

Time frame: Day 1. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	Single-dose (Cohort 1):0.03% SJP-0132 n = 6	Single-dose (Cohort 2):0.1% SJP-0132 n = 6	Single-dose (Cohort 3):0.3% SJP-0132 n = 5	Single-dose (Cohort 4):1% SJP-0132 n = 4	Multiple-dose (Cohort 5):0.3% SJP-0132 n = 12	Multiple-dose (Cohort 6):1% SJP-0132 n = 12
Value	0.28671 (0.158116)	1.02449 (0.827814)	0.85442 (0.462688)	5.15571 (2.537673)	0.32305 (0.178608)	1.14604 (1.024450)

Population analysed: Pharmacokinetic Set

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 2 for cohort 1-4, Day 29 for cohort 5-6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-dose (Cohort 1) : SJP-0132 Low Dose	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single-dose (Cohort 2) : SJP-0132 Mid-Low Dose	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single-dose (Cohort 3) : SJP-0132 Mid-High Dose	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Single-dose (Cohort 4) : SJP-0132 High Dose	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Single-dose (Cohort 1-4) : Placebo	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Multiple-dose (Cohort 5) : SJP-0132 Mid-High Dose	0 of 20 (0%)	1 of 20 (5%)	0 of 20
Multiple-dose (Cohort 6) : SJP-0132 High Dose	0 of 20 (0%)	5 of 20 (25%)	0 of 20
Multiple-dose (Cohort 5, 6) : Placebo	0 of 20 (0%)	7 of 20 (35%)	0 of 20

Limitations and caveats (from the sponsor): All of the efficacy and safety measurements applied in this study are widely used and generally recognized as reliable, accurate, and relevant.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SJP-0132 in people with Dry Eye Disease and Dry Eye Syndrome, run by Senju Pharmaceutical Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events by Severity in Each Cohort (time frame: Day 2 for cohort 1-4, Day 29 for cohort 5-6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04139122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.