Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1-4: SJP-0132 Each cohort will receive a single dose of 1 of 4 strengths of SJP-0132 |
Drug: SJP-0132
SJP-0132 is administered as an eye drop
|
| Placebo Comparator: Cohort 1-4: Placebo Single dose of placebo |
Drug: Placebo
Placebo is administered as an eye drop
|
| Experimental: Cohort 5-6: SJP-0132 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 |
Drug: SJP-0132
SJP-0132 is administered as an eye drop
|
| Placebo Comparator: Cohort 5-6: Placebo Multiple dose placebo for 4 weeks |
Drug: Placebo
Placebo is administered as an eye drop
|
Outcome Measures
Primary Outcome Measures
- Number and severity (mild, moderate, or severe) of adverse events in each cohort [Day 2 for cohort 1-4, Day 36 for cohort 5-6]
- 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 36 for cohort 5-6]
- Maximum plasma concentration (Cmax) in each cohort [Day 1]
- Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUC0-last) in each cohort [Day 1]
- Accumulation ratio (Rac) in cohort 5-6 [Day 8]
- Change from baseline in eye dryness symptom (visual analog scale [VAS]) [Day 29]
- Change from baseline in corneal fluorescein staining (CFS) score at the central zone [Day 29]
Secondary Outcome Measures
- Change from baseline in corneal fluorescein staining (CFS) score at the zones other than central zone (superior, inferior, nasal, and temporal zones) [Day 29]
- Change from baseline in conjunctival lissamine green staining (CLGS) of bulbar conjunctiva [Day 29]
- Change from baseline in lid wiper epitheliopathy score [Day 29]
- Change from baseline in tear film break-up time (TFBUT) [Day 29]
- Change from baseline in ocular surface disease index (OSDI®) [Day 29]
- Change from baseline in Dry eye Questionnaire 5 (DEQ-5) scores [Day 29]
- Biomarker (Matrix Metalloproteinase-9 [MMP-9], InflammaDry®) [Day 29]
Eligibility Criteria
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
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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.
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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
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Have a positive urine alcohol or urine drug test at Screening or Day -1
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Contact lens wearers who cannot discontinue the wear over the trial period
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Have undergone eye surgery (including laser surgery) within the last 12 months or whom the Investigator considers unsuitable
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Have a best corrected visual acuity (BCVA) worse than 20/100 in either eye
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Senju Investigational Site | Cypress | California | United States | 90630 |
Sponsors and Collaborators
- Senju Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SJP-0132/1-01