A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR)

Exclusion criteria

• ✕. Participants scheduled for simultaneous bilateral or 2nd-eye cataract surgery (note, subjects scheduled for a future 2nd eye cataract study are eligible for the study).
• ✕. Known sensitivity to benzodiazepines or ketamine.
• ✕. Known sensitivity to -caines (including proparacaine), benzalkonium chloride (BAK).
• ✕. Intraocular pressure (IOP) ≥ 23 mmHg in the study eye and/or ≥ 30 mmHg in the fellow eye at screening. This IOP exclusion requirement will only need to be re-confirmed on the day of surgery if it has been \> 14 days since the screening visit.
• ✕. History of iritis, or any ocular trauma with iris damage in the study eye.
• ✕. Presence of active corneal pathology other than corneal pathology per slit lamp and an external eye exam at screening in either eye.
• ✕. Presence of extraocular/intraocular inflammation in either eye.
• ✕. Presence of active bacterial and/or viral infection in either eye.