Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Loteprednol Etabonate · 6 trials · 5 indications
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. Lower score indicated better outcome. 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 the 6-point scale, with 0=None and 5=Severe.
Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D \[g20 Diopter\] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal 1. = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal 2. = Moderate Moderate anterior chamber clouding 3. = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished 4. = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain
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
When possible, plasma concentrations by scheduled time point and PK parameters (AUC0-t (Area under the time-concentration curve to the last measured time point) will be summarized using descriptive statistics by Visit.
| Arm | Type | Description |
|---|---|---|
| Loteprednol Etabonate Gel (BID) | EXPERIMENTAL | Loteprednol Etabonate Gel 0.38% administered two times daily (BID) |
| Vehicle Gel (BID) | PLACEBO_COMPARATOR | Vehicle gel administered two times daily (BID) |
| Vehicle (BID) | ACTIVE_COMPARATOR | Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID). |
| Loteprednol Etabonate Gel (TID) | EXPERIMENTAL | Loteprednol Gel 0.38% administered three times daily (TID). |
| Vehicle (TID) | ACTIVE_COMPARATOR | Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID). |
| Loteprednol etabonate | EXPERIMENTAL | Loteprednol etabonate 0.5% |
| Prednisolones acetate | ACTIVE_COMPARATOR | Prednisolone acetate 1.0% |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of loteprednol etabonate ophthalmic suspension |
| Loteprednol Etabonate Ophthalmic Gel | EXPERIMENTAL | one drop per eye for each eye |
| Name | Type | Description |
|---|---|---|
| Loteprednol Etabonate Gel (BID) | DRUG | One drop of LE gel instilled into the study eye two times per day (BID) for 14 days |
| Vehicle Gel (BID) | DRUG | One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days |
| Loteprednol Etabonate Gel (TID) | DRUG | One drop of LE gel instilled into the study eye three times per day (TID) for 14 days. |
| Vehicle (BID) | DRUG | One drop of vehicle instilled into the study eye two times per day (BID) for 14 days |
| Vehicle (TID) | DRUG | One drop of vehicle instilled into the study eye three times per day (TID) for 14 days |
| Loteprednol etabonate | DRUG | 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
| Prednisolones acetate | DRUG | 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
| Vehicle of Loteprednol Etabonate | DRUG | Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14. |
| Vehicle of Ophthalmic Loteprednol Etabonate | DRUG | Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days. |
Inclusion Criteria: Visit 1 (Screening Visit) * Be willing and able to comply with all treatment and follow-up/study procedures. * Be a candidate for routine, uncomplicated cataract surgery. Visit 3 (Postoperative Day 1) * Have undergone routine, uncomplicated cataract surgery (phaco-emulsificat...
Loteprednol Etabonate is a small molecule being developed for ocular conditions including cataract, dry eye, inflammation, ocular inflammation, and seasonal allergic conjunctivitis. It is an investigational drug in clinical development, studied in completed trials for these indications.
Loteprednol Etabonate is developed by Bausch + Lomb Corporation, traded on the New York Stock Exchange under the ticker BLCO. The company is conducting clinical research on this ophthalmic drug candidate.
Loteprednol Etabonate is in Phase 1 development, though its completed clinical trials include Phase 2 and Phase 3 studies. It is an investigational drug, not yet approved, and remains in clinical development for ocular indications.
Loteprednol Etabonate has completed three trials: NCT00560638 for dry eye, NCT00699153 for ocular inflammation after cataract surgery, and NCT01435460 for seasonal allergic conjunctivitis. A fourth trial, NCT01475643, studied it for intraocular inflammation following cataract surgery in children.
Loteprednol Etabonate is a corticosteroid, but its specific molecular target is not disclosed in available data. It is being studied for its anti-inflammatory effects in ocular conditions such as inflammation and allergic conjunctivitis.