Structure Multicenter, randomized, double-masked, vehicle-controlled, parallel group study.~Duration~1 month of TID treatment.~Treatment Groups, Dosing, and Treatment Regimen~Study Treatment CBT-008 topical ophthalmic solution CBT-008 ophthalmic solution is a sterile, preservative-free ophthalmic solution containing CBT-008 (2.5 and 10%), sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.~Control Treatment CBT-008 vehicle CBT-008 vehicle ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.~Methods for Masking Study medication will be packaged in identical kits and will be labeled with medication kit numbers. The central randomization system will provide the site with a specific medication kit number for the patient corresponding to the treatment group assigned.~Instructions for Storage, Use, and Administration Study medication will be supplied as preservative free-unit dose containers, where 1 mL of CBT-008 ophthalmic solution will be aseptically filled into 3 mL Low Density Polyethylene (LDPE) ophthalmic dropper bottles. Study medication should be stored at room temperature in a secure area at clinical sites and dispensed only to patients enrolled into the clinical study. Patients will be instructed to store study medication in a cool place at room temperature at home. Study medication will be administered TID, one drop, to both eyes. First instillation of study medication on the first day will be applied by subject or care provider with site staff's observation for training and supervision. During the rest of the study treatment, patients will self-administer the medication TID for 1 month.
Study Design~Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study Duration: 1 month of TID treatment Treatment Groups, Dosing, and Treatment Regimen Study Treatment: CBT-008 topical ophthalmic solution Control Treatment: CBT-008 vehicle