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

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.