Clinical trial NCT04139122: Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye Disease
Dry Eye Syndrome
Lead sponsor: Senju Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-25
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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/Exclusion Criteria may apply

Primary outcomes:
measure: Number of Participants With Adverse Events by Severity in Each Cohort
timeFrame: Day 2 for cohort 1-4, Day 29 for cohort 5-6
measure: Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort
timeFrame: Day 2 for cohort 1-4, Day 29 for cohort 5-6
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Day 1
measure: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last)
timeFrame: Day 1
measure: Accumulation Ratio (Rac) After Multiple Dosing
timeFrame: Day 2, 4, 8
measure: Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29
timeFrame: Day 29
measure: Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29
timeFrame: Day 29
Secondary outcomes:
measure: Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints
timeFrame: Day 29
measure: Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints
timeFrame: Day 8, 15, 22, 29
measure: Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints
timeFrame: Day 8, 15, 22, 29
measure: Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints
timeFrame: Day 8, 15, 22, 29
measure: Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints
timeFrame: Day 8, 15, 22, 29
measure: Change From Baseline in Ocular Surface Disease Index (OSDI)
timeFrame: Day 8, 15, 22, 29
measure: Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores
timeFrame: Day 29
measure: Change in Matrix Metalloproteinase-9 (MMP-9)
timeFrame: Day 29
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Senju Investigational Site
state: California
Study officials:
References: