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Loteprednol Etabonate dosed · 1 trial · 3 indications
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...
Loteprednol Etabonate dosed is an investigational small molecule being studied for the treatment of ocular inflammation and pain following cataract surgery. It is a corticosteroid formulated as a gel and is currently in Phase 3 clinical development for this indication.
Loteprednol Etabonate dosed is being developed by Bausch + Lomb Corporation, which trades under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients undergoing cataract surgery.
Loteprednol Etabonate dosed is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not currently in active clinical trials.
Loteprednol Etabonate dosed was studied in a completed Phase 3 trial with the identifier NCT02786901. This randomized, double-blind, placebo-controlled trial enrolled 600 participants in the United States to evaluate the drug for ocular inflammation and pain following cataract surgery.
Loteprednol Etabonate dosed is a corticosteroid that works by reducing inflammation in the eye. It is designed to treat ocular inflammation and pain that can occur after cataract surgery, helping to manage the postoperative inflammatory response.