Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
0.5% Loteprednol Etabonate · 1 trial · 1 indication
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
| Arm | Type | Description |
|---|---|---|
| Loteprednol Etabonate | EXPERIMENTAL | Loteprednol etabonate 0.5% ophthalmic ointment |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of loteprednol etabonate ointment |
| Name | Type | Description |
|---|---|---|
| 0.5% Loteprednol Etabonate Ophthalmic Ointment | DRUG | 1/2 inch ribbon four times a day for 14 days |
| Vehicle of Loteprednol Etabonate Ophthalmic Ointment | DRUG | 1/2 inch ribbon four times a day for 14 days |
Inclusion Criteria: 1. Subjects who are candidate for routine, uncomplicated cataract surgery 2. Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye. Exclusion Criteria: 1. Subjects who will require conc...
0.5% Loteprednol Etabonate is an ophthalmic ointment used for the treatment of ocular inflammation, specifically inflammation following cataract surgery. It is a small molecule being developed by Bausch + Lomb Corporation for use in ophthalmology.
0.5% Loteprednol Etabonate is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical research on this ophthalmic ointment for the treatment of ocular inflammation.
0.5% Loteprednol Etabonate is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 3 trial has been completed, involving 400 participants.
0.5% Loteprednol Etabonate has one completed Phase 3 trial, NCT00645671, titled 'Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery.' This randomized, double-blind, placebo-controlled trial enrolled 400 participants in the United States.
0.5% Loteprednol Etabonate is a specific concentration of the drug Loteprednol Etabonate. The 0.5% formulation is being studied as an ophthalmic ointment for ocular inflammation following cataract surgery.