Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Loteprednol etabonate base (QD)
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 being developed for allergic conjunctivitis, an inflammatory eye condition. It is a small molecule formulated as an ophthalmic product and was studied in a Phase 2 allergen challenge trial. It is investigational and has not been approved for this use.
Loteprednol etabonate base is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company sponsored the Phase 2 allergen challenge study of the ophthalmic base formulation in allergic conjunctivitis.
Loteprednol etabonate base is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. It remains an investigational product and is not approved for allergic conjunctivitis.
Loteprednol etabonate base has been studied in NCT01107405, a completed Phase 2 trial titled Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge. The trial enrolled 101 participants in the United States and was randomized, double blind, and placebo controlled.
Yes, loteprednol etabonate base (QD) is an alternative name for loteprednol etabonate base. Both refer to the same ophthalmic small molecule developed by Bausch + Lomb Corporation for allergic conjunctivitis.