A multicenter, Investigator - masked, parallel-group, randomized study of the efficacy and safety of loteprednol etabonate 0.5% eyedrops versus dexamethasone 0.1% eyedrops in the treatment of ocular inflammation following cataract surgery. - Study#541-Lteprednol etabonate vs Dexamethasone

INTERVENTION: Trade Name: LOTEMAX Pharmaceutical Form: Eye drops, suspension INN or Proposed INN: Loteprednol Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 190‐ CONDITION: Subjects scheduled to undergo cataract surgery ; MedDRA version: 9.1 Level: SOC Classification code 10015919 Term: Eye disorders PRIMARY OUTCOME: Main Objective: The objective of this study is to demonstrate that LE ophthalmic suspension 0.5% is non‐inferior to dexamethasone 0.1% in the treatment of ocular inflammation following uncomplicated cataract surgery when administered in combination with a preoperative and postoperative regimen of indomethacin 0.1% Primary end point(s): Efficacy The primary endpoint is the prevention/reduction of ocular inflammation, defined as an absence or reduction from Day 1 to Day 7 in both flare and cells, will be measured through the slit lamp/biomicroscopy examination. Safety Adverse Events: information regarding any subject‐ or Investigator‐reported AEs will be obtained at each study visit.Retrospective subjective tolerance to study drug upon instillation will be assessed at Day 7 and Day 14. Tolerance will be rated by the subject on a scale from 1 to 4, where 1 = Very Good and 4 = Very Bad. BCVA will be obtained at the Day 7, Day 14, and Day 60 Visits. IOP will be measured at Day 7, Day 14, and Day 60. Fundoscopy will be performed at Day 14 and Day 60. Secondary Objective: The secondary efficacy endpoints include the following: Anterior chamber flare and cells at Day 7, Day 14 and Day 60 will be measured through the slit lamp/biomicroscopy examination. Retinal thickness will be measured with an OCT3 machine at the Screening Visit, Day 1, Day 14 and Day 60. The change from Day 1 central retinal thickness of the study eye and the mean change from Day 1 of 4 pericentral quadrants will be assessed. Conjunctival hyperaemia and perikeratic circle, will be measured through the slit lamp/biomicroscopy examinations at Day 1, Day 7, Day 14 and Day 60. INCLUSION CRITERIA: Subjects enrolled in this study must satisfy the following INCLUSION CRITERIA: 1. Must be of legal age (at least 18) and have full legal capacity to volunteer, 2. Must read, understand, and sign the IEC approved Informed Consent Form (ICF), and provide authorization as appropriate for local privacy regulations, 3. Must be scheduled to undergo cataract surgery in one eye, involving phacoemulsification with posterior chamber IOL implantation using topical anesthesia, 4. Females who are sexually active must fall into one of the following categories: Post menopausal Surgically sterile Currently using one of the following birth control methods throughout the duration of the study: ‐Intrauterine device (>14 days) ‐Barrier method (condom or diaphragm) with spermicide (>14 days) ‐Hormonal contraception (same dose and same formulation for at least six months 5. Women of childbearing potential who have a negative urine pregnancy test, 6. Must be will