Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2)

Exclusion Criteria

• •1. Systemic administration of any corticosteroid or immunosuppressant drugs in the previous 2 weeks prior to the first instillation of the investigational medical product (IMP)
• •2. Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to the first instillation of the IMP, or of any corticosteroid depot within 2 months prior to the first instillation of the IMP (Ozurdex® \[dexamethasone\]: within prior 6 months; Iluvien® \[fluocinolone\]: within prior 36 months)
• •3. Instillation of any topical ocular corticosteroid, non-steroidal antiinflammatory drug (NSAID), mast cells stabilizers, antihistamines or decongestants within 2 weeks prior to the first instillation of the IMP, except pre-surgical and/or surgical administration of 1 drop of a topical NSAID or corticosteroid, at the investigator discretion
• •4. Prescription of any topical ocular medication, except preservative-free antibiotics for prophylactic purposes
• •5. Any history of glaucoma or ocular hypertension in the study eye
• •6. History or presence of endogenous uveitis
• •7. Any current corneal abrasion or ulceration
• •8. Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease
• •9. Known hypersensitivity or contraindication to the study drug or any of its components
• •10. History of steroid-related intraocular pressure (IOP) increase
• •11. Previous surgery in the last 4 weeks prior to the Screening visit or new surgery scheduled to be performed before the end of the study period on the contralateral eye
• •12. Presence of ocular hemorrhage which interferes with the evaluation of post-surgery inflammation
• •13. Presence of intraoperative complications during the cataract surgical procedure that may increase post-operative inflammation; this includes, in particular, patients with ocular hemorrhage, floppy iris syndrome, increased IOP (≥24 mmHg), posterior capsule rupture and injections of gas into the vitreous body
• •14. Increased cumulative dissipated energy value during phacoemulsification (increased energy used for phacoemulsification exert additional stress on iris and other anterior chamber structures and may generate excessive inflammation)
• •15. Presence of zonular dialysis (rupture of zonular fibers that attach lens to the ciliar body which may lead to partial luxation of the lens / lens capsule and is a serious complication of cataract surgery)
• •16. Presence of Fuchs´ endothelial dystrophy (loss of endothelial cells that may result in chronic corneal edema after cataract surgery especially if high energy was used during phacoemulsification)
• •17. Presence of cornea guttata
• •18. Pupil dilation lower than 4.5 mm
• •19. Presence of lower lacrimal duct obstruction and/or history of infectious dacryocystitis
• •20. Presence of IOP ≥24 mmHg at Baseline visit
• •21. Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to the Screening visit, or at any time during the study
• •22. Prior participation in the study described in this protocol, unless patient was not randomized
• •23. In the opinion of the investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
• •24. Disease, condition (including monocular participants), or disorder that in the judgement of investigator could confound study assessments or limit compliance to study protocol