A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

Summary

A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Senju Pharmaceutical Co., Ltd.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Signed informed consent form (ICF).

• Has Dry Eye Disease (DED) with moderate to severe corneal fluorescein staining in both eyes.

• Has blurred vision caused by DED in both eyes.

• Women of childbearing potential must have negative serum pregnancy test results at Screening and Randomization and agree to use effective contraception throughout the study; post-menopausal women must have negative serum pregnancy test results at Screening and Randomization.

• Male participants must agree to use an acceptable form of contraception (i.e. a condom plus spermicide) and to refrain from sperm donation throughout the study.

Exclusion Criteria:

• Has any corneal stromal or endothelial abnormalities in either eye.

• Has any active or chronic allergic, bacterial or viral infection of ocular adnexa and eye structures in either eye.

• Has had eye surgery (including cataract, vitreous or eyelid surgery) in either eye within the last 28 days prior to first dose of study drug.

• Has had refractive surgery (including eye surface laser surgery) in either eye within the last 180 days prior to first dose of study drug.

• Has used any eye medication in either eye within 14 days prior to first dose of study drug, or is anticipated to require such medications during the study. Preservative-free artificial tears may be used up to 72 hours prior to the first dose in either eye.

• Is a contact lens wearer and cannot discontinue use in both eyes from Screening through the duration of the study.

• Has previously received SJP-0035 (study drug) in either eye.

• Currently has punctal occlusions, of any type, inserted into both superior and inferior puncta in either eye at Screening through the duration of the study.

Other protocol-defined inclusion/exclusion criteria could apply.