Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)

WW-2020-DexSMILE

This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

2020-06-18

2021-06-21

2021-06-21

Completed

Early phase I

20

Inclusion Criteria: * Age 18 years and older * Scheduled for bilateral SMILE surgery * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form Exclusion Criteria: * Patients under the age of 18. * Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Obstructed nasolacrimal duct in the study eye(s) * Hypersensitivity to dexamethasone * Patients being treated with immunomodulating agents in the study eye(s) * Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2023-10-06