Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1)

Inclusion Criteria:

1. Male or female, age 18 years or older on day of consent
2. Participants with routine unilateral cataract surgery on the day prior to studyrandomization
3. Participants with at least 5 cells in anterior chamber on the first day after surgery (at Baseline visit)
4. Willing and able to understand and provide written informed consent form (ICF) (atScreening visit)
5. Women who satisfy one of the following:
6. Are of child-bearing potential who are not pregnant or lactating and who areeither abstinent or sexually active on an acceptable method of birth control (methods that can achieve a failure rate of less than 1% per year when usedconsistently and correctly, like hormonal contraception (oral pills, implantabledevice, or skin patch), intrauterine device, bilateral tubal occlusion, or doublebarrier) for at least 4 weeks prior to Baseline visit and throughout the study (i.e., until Day 29), OR
7. Are post-menopausal (have had no menstrual cycle for at least one year prior toScreening visit) or have undergone a sterilization procedure (bilateral tuballigation, hysterectomy, hysterectomy with unilateral or bilateral oophorectomy orbilateral oophorectomy) at least 6 months prior to Screening visit

Exclusion Criteria:

1. Systemic administration of any corticosteroid or immunosuppressant drugs in theprevious 2 weeks prior to the first instillation of the investigational medicalproduct (IMP)
2. Periocular injection in the study eye of any corticosteroid solution within 4 weeksprior to the first instillation of the IMP, or of any corticosteroid depot within 2months prior to the first instillation of the investigational medical product (Ozurdex® [dexamethasone]: within prior 6 months; Iluvien® [fluocinolone]: withinprior 36 months)
3. Instillation of any topical ocular corticosteroid, non-steroidal antiinflammatory drug (NSAID), mast cells stabilizers, antihistamines or decongestants within 2 weeks priorto the first instillation of the IMP, except pre-surgical and/or surgicaladministration of 1 drop of a topical NSAID or corticosteroid, at the investigatordiscretion
4. Prescription of any topical ocular medication, except preservative-free antibioticsfor 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 keratoconjunctivaldisease
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 surgeryscheduled 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-surgeryinflammation
13. Presence of intraoperative complications during the cataract surgical procedure thatmay increase post-operative inflammation; this includes, in particular, participantswith ocular hemorrhage, floppy iris syndrome, increased IOP (≥24 mmHg), posteriorcapsule rupture and injections of gas into the vitreous body
14. Increased cumulative dissipated energy value during phacoemulsification (increasedenergy used for phacoemulsification exert additional stress on iris and other anteriorchamber structures and may generate excessive inflammation)
15. Presence of zonular dialysis (rupture of zonular fibers that attach lens to the ciliarbody which may lead to partial luxation of the lens / lens capsule and is a seriouscomplication of cataract surgery)
16. Presence of Fuchs´ endothelial dystrophy (loss of endothelial cells that may result inchronic corneal edema after cataract surgery especially if high energy was used duringphacoemulsification)
17. Presence of cornea guttata
18. Pupil dilation lower than 4.5 mm
19. Presence of lower lacrimal duct obstruction and/or history of infectiousdacryocystitis
20. Presence of IOP ≥24 mmHg at Baseline visit
21. Participation in any study of an investigational topical or systemic new drug ordevice 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 participant wasnot randomized
23. In the opinion of the investigator or study coordinator, be unwilling or unable tocomply with study protocol or unable to successfully instill eye drops
24. Disease, condition (including monocular participants), or disorder that in thejudgement of investigator could confound study assessments or limit compliance tostudy protocol