Approval Probability
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ML Risk
Loteprednol etabonate base · 1 trial · 1 indication
Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
| Arm | Type | Description |
|---|---|---|
| Loteprednol etabonate base (QD) | ACTIVE_COMPARATOR | Loteprednol etabonate ophthalmic base dosed once/day. |
| Loteprednol etabonate base (BID) | ACTIVE_COMPARATOR | Loteprednol etabonate ophthalmic base dosed two times/day |
| Loteprednol etabonate base (QID) | ACTIVE_COMPARATOR | Loteprednol etabonate ophthalmic base dosed four times/day. |
| Loteprednol etabonate suspension (QID) | ACTIVE_COMPARATOR | Loteprednol etabonate ophthalmic suspension dosed four times/day |
| Vehicle of loteprednol etabonate | PLACEBO_COMPARATOR | Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
| Name | Type | Description |
|---|---|---|
| Loteprednol etabonate base (QD) | DRUG | Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks |
| Loteprednol etabonate base (BID) | DRUG | Loteprednol etabonate ophthalmic base BID dosing for 2 weeks |
| Loteprednol etabonate base (QID) | DRUG | Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week |
| Loteprednol etabonate suspension | DRUG | Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks. |
| Vehicle of loteprednol etabonate | DRUG | Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks. |
Inclusion Criteria: * Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months. * Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart. * Positive ...
Loteprednol etabonate base is an investigational small molecule being studied for the treatment of allergic conjunctivitis, a condition involving inflammation of the conjunctiva due to an allergic reaction. It is administered as an ophthalmic formulation and is currently in Phase 2 clinical development.
Loteprednol etabonate base is a corticosteroid that works by reducing inflammation in the eye. It is designed to treat allergic conjunctivitis by suppressing the inflammatory response associated with the allergic reaction, thereby alleviating symptoms such as redness, itching, and swelling.
Loteprednol etabonate base is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical research to evaluate the drug's safety and efficacy for allergic conjunctivitis.
Loteprednol etabonate base is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its effects in patients with allergic conjunctivitis.
Loteprednol etabonate base has been studied in one completed Phase 2 clinical trial, identified as NCT01107405. This randomized, double-blind, placebo-controlled trial enrolled 101 participants with allergic conjunctivitis in the United States and compared the drug to a suspension formulation and placebo.
Loteprednol etabonate base is a specific formulation of loteprednol etabonate, a corticosteroid used in ophthalmology. The base form is being investigated as an ophthalmic treatment for allergic conjunctivitis, and it has been compared directly to a suspension formulation of loteprednol etabonate in clinical trials.