Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Senju Pharmaceutical Co., Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
