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Also known as 0.5% Loteprednol Etabonate Ophthalmic Ointment
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 investigational small molecule ophthalmic ointment being developed for ocular inflammation. It is formulated as a topical eye ointment and is being studied in patients with inflammation following cataract surgery. It is not yet approved and remains in clinical development.
0.5% Loteprednol Etabonate is being studied for the treatment of ocular inflammation, specifically inflammation following cataract surgery. The clinical program enrolled adults aged 18 years and older with this condition. It is investigational and has not been approved for commercial use.
Bausch + Lomb Corporation, which trades under the ticker BLCO, is developing 0.5% Loteprednol Etabonate. The company is the sponsor of the clinical program evaluating the ophthalmic ointment for ocular inflammation following cataract surgery.
0.5% Loteprednol Etabonate is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for ocular inflammation.
0.5% Loteprednol Etabonate has been evaluated in one completed Phase 3 trial, NCT00645671, titled Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery. The trial enrolled 400 patients in the United States and was randomized, double blind, and placebo controlled.
Yes, 0.5% Loteprednol Etabonate Ophthalmic Ointment is another name for 0.5% Loteprednol Etabonate. Both refer to the same investigational small molecule product developed by Bausch + Lomb Corporation for ocular inflammation following cataract surgery.