Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02786901 | LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery | PHASE3 | COMPLETED | 600 | — | — | Jun 1, 2016 | Jul 1, 2017 | Jan 8, 2021 | 6 | United States |
Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye.
Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0.
| Arm | Type | Description |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel dosed TID | EXPERIMENTAL | Gel |
| Loteprednol Etabonate Ophthalmic Gel dosed BID | EXPERIMENTAL | Gel |
| Vehicle Gel | PLACEBO_COMPARATOR | Vehicle |
| Name | Type | Description |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel dosed TID | DRUG | Gel |
| Loteprednol Etabonate Ophthalmic Gel dosed BID | DRUG | Gel |
| Vehicle Gel | DRUG | Gel |
Key Inclusion Criteria: 1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent. 2. Be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) appro...