Approval Probability
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Adjusted LOA
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Lotemax · 1 trial · 1 indication
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 |
|---|---|---|
| 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). |
| Name | Type | Description |
|---|---|---|
| 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 | - |
Inclusion Criteria: * Have been diagnosed with or treated for keratoconjunctivitis sicca (DED) within 6 months prior to screening visit (Day -14). * Have a baseline intraocular pressure (IOP) measurement of greater than or equal to (≥) 5 millimeters of mercury (mmHg) and less than or equal to (≤) 2...
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.