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Label indication Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to… FDA label
Also known as loteprednol etabonate ophthalmic gel 0.5%, Loteprednol Etabonate, LE Gel, Loteprednol Etabonate Gel (BID), Loteprednol Etabonate Gel (TID)
Lotemax · 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
Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the National Eye Institute (NEI) grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regions, ranged from 0 (absence of corneal epitheliopathy) to 15 (severe corneal epitheliopathy).
OSDI is a 12-item questionnaire developed to assess severity of DED. There are 3 question types: "Have you experienced any of following (light sensitivity, eye feel gritty, sore eyes, blurred vision, and poor vision) during last week?"(items 1-5); "Have problems with your eyes limited you in performing any of following (reading, driving at night, working with computer, and watching TV) during last week?" (items 6-9); and "Have your eyes felt uncomfortable in any of following situations (windy, low humidity, air conditioned) during the last week?" (items 10-12). Response of each of these questions were graded on a scale (that relate to the frequency of ocular surface disease effects) of 0 (none of the time) to 4 (all of the time).Total OSDI score was calculated using following formula: OSDI=(\[sum of scores for all questions answered\] × 100)/(\[total number of questions answered\] \* 4). Total OSDI score ranged from 0 to 100, with higher scores representing greater disability.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Participants scored their degree of comfort with their assigned study drug on a 4-point scale (0-3 units) within 5 minutes after instillation of study drug. Comfort grade 0 indicated comfortable, discomfort absent; 1 indicated generally comfortable, mild discomfort; 2 indicated some discomfort but tolerable, moderate discomfort; 3 indicated severely uncomfortable or intolerable. The mean global ocular comfort grade was reported.
| 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 |
| Lotemax Gel 0.5% and Restasis 0.05% | EXPERIMENTAL | Participants will administer lotemax gel 0.5 % BID in both eyes (OU) for 2 weeks, then administer both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administer restasis emulsion 0.05% BID OU for 8 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day). |
| Lotemax Gel 0.5% | EXPERIMENTAL | Participants will administer lotemax gel 0.5% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day). |
| Restasis 0.05% | ACTIVE_COMPARATOR | Participants will administer restasis emulsion 0.05% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day). |
| Loteprednol Etabonate TID | EXPERIMENTAL | loteprednol etabonate ophthalmic suspension, 0.5%, TID |
| Loteprednol Etabonate QID | EXPERIMENTAL | loteprednol etabonate ophthalmic suspension, 0.5%, QID |
| 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. |
| Lotemax | DRUG | Lotemax gel will be administered as per the dose and schedule specified in the arms. |
| Restasis | DRUG | Restasis emulsion will be administered as per the dose and schedule specified in the arms. |
| Soothe® Lubricant Eye Drops | DRUG | - |
| loteprednol etabonate ophthalmic suspension, 0.5% | DRUG | TID |
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...
Lotemax is an ophthalmic small molecule being studied for keratoconjunctivitis sicca, also known as dry eye disease. It is a loteprednol etabonate gel 0.5% formulation under investigation for mild or moderate cases of the condition. The drug is in Phase 2 clinical development.
Lotemax is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical research on the drug for the treatment of keratoconjunctivitis sicca, or dry eye disease.
Lotemax is in Phase 2 clinical development for keratoconjunctivitis sicca. It is an investigational drug and has not been approved for this indication. One Phase 2 clinical trial for the drug has been completed.
Lotemax has one completed Phase 2 clinical trial, identified as NCT01817582. The study evaluated Lotemax Gel 0.5% compared with Restasis 0.05% in 102 participants with mild or moderate keratoconjunctivitis sicca in the United States. The trial enrolled adults aged 40 years and older.
Lotemax is a brand name for a formulation of loteprednol etabonate, specifically a 0.5% ophthalmic gel. It is being studied for keratoconjunctivitis sicca, or dry eye disease, and is in Phase 2 clinical development by Bausch + Lomb Corporation.