Ocular Pain Following Bilateral Photorefractive Keratotomy (PRK) Clinical Trial
Official title:
An Investigator Initiated, Randomized, Single Center Clinical Study to Evaluate the Safety, Efficacy, and Wearability Using the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing a Photorefractive Keratotomy Procedures (PRK)
The goal of this clinical trial is to determine the safety, efficacy, and comfort of the investigational TetraLens bandage contact lens in patients who have undergone photorefractive keratectomy (PRK). The main question[s] it aims to answer are: - Understand benefit of managing pain following the surgical procedure - Understand the safety of the Tetralens Participants will be asked to wear theTetraLens BCL in one eye for 6 days post-operatively and: document the daily quantity of oral analgesics needed and report ocular pain and contact lens comfort. Researchers will compare the study lens in one eye to a control lens in the contralateral (other eye)
The safety and efficacy of the methafilcon A and tetracaine HCL components of the TetraLens BCL have safety and efficacy profiles that are well established. This study aims to obtain the initial assessment of the safety efficacy and wearability of the TetraLens BCL for use a therapeutic bandage contact lens for short-term topical pain relief following ocular surgery. ;