Investigation of a Sub-Conjunctival Insert

Exclusion Criteria

• •Inability to follow the protocol schedule
• •Participating in another clinical study
• •Pregnant or lactating females
• •Any ongoing condition that would prevent from proper handling of the instrument (e.g. blindness, strong impaired vision, impaired motor skills)
• •Any known hypersensitivity to any of the products to be used in the study, including preservatives etc.
• •Malignancies requiring therapy during the study
• •Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study
• •Poorly controlled diabetes mellitus with prior hemoglobin A1C greater than 10%
• •Any ocular disease requiring topical medication besides those permitted by this protocol.
• •Ocular or other condition which increase the risk of ocular surgery, e.g. acute or chronic conjunctivitis or blepharitis, corneal disorders, previous eye surgery or eye surgery within the following 12 weeks, coagulation disorders.