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

Senju Pharmaceutical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye Disease; Dry Eye Syndrome

Treatments: Drug: SJP-0132; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04139122

SJP-0132/1-01

Details and patient eligibility

About

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

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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89 participants in 4 patient groups, including a placebo group

Cohort 1-4: SJP-0132

Experimental group

Description:

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

Treatment:

Drug: SJP-0132

Cohort 1-4: Placebo

Placebo Comparator group

Description:

Single dose of placebo

Treatment:

Drug: Placebo

Cohort 5-6: SJP-0132

Experimental group

Description:

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

Treatment:

Drug: SJP-0132

Cohort 5-6: Placebo

Placebo Comparator group

Description:

Multiple dose placebo for 4 weeks

Treatment:

Drug: Placebo