Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LE Gel, Loteprednol Etabonate Ophthalmic Gel dosed TID, Loteprednol Etabonate Ophthalmic Gel dosed BID, Loteprednol etabonate
LE · 10 trials · 7 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.
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
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
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
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
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
Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose
| Arm | Type | Description |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel dosed TID | EXPERIMENTAL | Gel |
| Loteprednol Etabonate Ophthalmic Gel dosed BID | EXPERIMENTAL | Gel |
| Vehicle Gel | PLACEBO_COMPARATOR | Vehicle |
| 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% |
| Alrex | EXPERIMENTAL | Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% |
| Patanol | ACTIVE_COMPARATOR | Ophthalmic solution containing olopatadine, 0.1% |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of loteprednol etabonate ophthalmic suspension |
| Loteprednol Etabonate TID | EXPERIMENTAL | loteprednol etabonate ophthalmic suspension, 0.5%, TID |
| Loteprednol Etabonate QID | EXPERIMENTAL | loteprednol etabonate ophthalmic suspension, 0.5%, QID |
| LE Gel | EXPERIMENTAL | A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears. |
| Name | Type | Description |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel dosed TID | DRUG | Gel |
| Loteprednol Etabonate Ophthalmic Gel dosed BID | DRUG | Gel |
| Vehicle Gel | DRUG | Gel |
| 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. |
| Loteprednol etabonate 0.2% | DRUG | 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks. |
| Olopatadine 0.1% | DRUG | 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks. |
| 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. |
| loteprednol etabonate ophthalmic suspension, 0.5% | DRUG | TID |
| LE Gel | DRUG | Single drop of LE Gel 0.5% administered to the study eye on visit 2 |
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...
LE is an investigational small molecule developed by Bausch + Lomb Corporation under the ticker BLCO. It is also known as LE Gel. The program is in Phase 1 clinical development, and its intended therapeutic indications have not been disclosed.
LE is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is the sponsor of the clinical work conducted on this asset.
LE is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
LE has been studied in one completed Phase 1 trial, NCT01736527, titled Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation. The trial enrolled 12 healthy adult volunteers in the United States and assessed pharmacokinetics.
Yes, LE Gel is another name for LE. Both names refer to the same investigational small molecule being developed by Bausch + Lomb Corporation under the ticker BLCO.