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

NCT ID: NCT04139122

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-05
• Study Completion Date: 2020-03-03

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

Conditions

Dry Eye Disease; Dry Eye Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cohort 1-4: SJP-0132

Each cohort will receive a single dose of 1 of 4 strengths of SJP-0132

Group Type: EXPERIMENTAL

SJP-0132

Intervention Type: DRUG

SJP-0132 is administered as an eye drop

Cohort 1-4: Placebo

Single dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is administered as an eye drop

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

Group Type: EXPERIMENTAL

SJP-0132

Intervention Type: DRUG

SJP-0132 is administered as an eye drop

Cohort 5-6: Placebo

Multiple dose placebo for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is administered as an eye drop

Interventions

SJP-0132

SJP-0132 is administered as an eye drop

Intervention Type: DRUG

Placebo

Placebo is administered as an eye drop

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Senju Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Senju Investigational Site

Cypress, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJP-0132/1-01

Identifier Type: -

Identifier Source: org_study_id