Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population

Inclusion Criteria:

• Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the dayof consent.

• Patients who are candidate for routine, uncomplicated cataract surgery in one eyewith or without intraocular lens.

• Patients whose caregiver(s) is/are able and willing to comply with all treatment andfollow-up procedures.

• Signed informed consent from (ICF) parents or patient's legally authorizedrepresentative(s).

• Patients who have undergone routine, uncomplicated cataract surgery in one eye withor without intraocular lens.

• Patients with clinical evidence of postoperative inflammation (anterior chamberinflammation grade > 0).

Exclusion Criteria:

• Presence of any active or suspected viral, bacterial, or fungal disease in the studyeye.

• Active uveitis in the study eye.

• Ocular neoplasia in the study eye.

• Post-traumatic cataract in the study eye.

• Suspected permanent low vision or blindness in the fellow non-study eye. The studyeye must not be the patient's only good eye.

• Use of any topical medication in the study eye within 2 days prior to surgery,except for those required for ocular examination or preoperative preparation.

• Systemic administration of any steroidal anti inflammatory drugs in the previous 2weeks prior to the surgery.

• Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery.

• Patient or patient's breastfeeding mother who is expected to use corticosteroids (except corticosteroid inhalers and dermatological corticosteroids, as long as theyare not used on the eyelids or surrounding area, and oral prednisolone steaglatedrops as part of the standard treatment after cataract surgery) orimmunosuppressants during the 30 days following cataract surgery.

• History of steroid-induced increase in IOP in either eye.

• Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapyin either eye or systemically.

• Any current corneal abrasion or ulceration.

• Known or suspected allergy or hypersensitivity to similar drugs, such as othercorticosteroids, or their components.

• Patients who have had ocular surgery in the study eye within 90 days prior tosurgery.

• History of post-operative unresolved inflammation in the contralateral eye.

• Presence or history of chronic generalized systemic disease that the Investigatorbelieves may either increase the risk to the subject or confound the results of thestudy (e.g., Diabetes mellitus, human immunodeficiency virus [HIV], acquiredimmunodeficiency syndrome [AIDS]).

• Any concurrent process which, in the opinion of the investigator, could impairpatients' safety or limit adherence to the study protocol.

• Participation in any study of an investigational topical or systemic new drug ordevice within 30 days prior to screening, or at any time during the study.

• Prior participation in the study described in this protocol unless the patientwasn't randomized.