Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

A Randomized, Double-Masked, Parallel-Group, Vehicle Controlled, Multicenter, Exploratory Study Assessing the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.

Inclusion Criteria:

• Subjects who have a diagnosis of dry eye disease.
• Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
• Subjects who are willing and able to refrain from using contact lenses during the study.

Exclusion Criteria:

• Subjects with known hypersensitivity or contraindication to any component of the study medication.
• Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
• Subjects who are expected to require treatment with corticosteroids during the study.
• Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
• Subjects who have undergone any type of ocular surgery within three months prior to screening.
• Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
• Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.