Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01107405 | Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge | PHASE2 | COMPLETED | 101 | — | — | Apr 1, 2010 | Aug 1, 2010 | Mar 21, 2012 | 1 | United States |
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 ...