A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

Inclusion Criteria:

• Is 0-5 years of age (up to the day before the subject turns 6 years of age). In theevent that a subject aged 0-5 years enrolls in the study and then undergoes a secondcataract surgery in the contralateral eye during the study period, the subject remainseligible for participation for both eyes, regardless if the second surgery occurs whenthe subject is >5 years of age)
• Has a cataract and is expected to undergo primary cataract surgery with or withoutimplantation of a posterior chamber intraocular lens

Exclusion Criteria:

• Any intraocular inflammation in the study eye present during the screening slit lampexamination
• Has ocular hypertension (defined as IOP of >21 mmHg), or glaucoma or is on medicationsto treat ocular hypertension or glaucoma or has a history of IOP spikes in either eyeincluding steroid-related IOP increases
• Evidence of acute external ocular infections (bacterial, viral and/or fungal such asvaccinia, varicella, and other viral diseases of the cornea and conjunctiva),tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocularinfections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitisin the study eye