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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01698554 | Bimatoprost in the Treatment of Eyelash Hypotrichosis | PHASE3 | COMPLETED | 464 | — | — | Nov 1, 2012 | Mar 1, 2014 | Feb 10, 2015 | 4 | United States, Russia +2 |
The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.
| Arm | Type | Description |
|---|---|---|
| bimatoprost formulation A solution | EXPERIMENTAL | Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| bimatoprost solution 0.03 % | ACTIVE_COMPARATOR | Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| vehicle of bimatoprost formulation A solution | PLACEBO_COMPARATOR | Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| vehicle of bimatoprost solution 0.03 % | PLACEBO_COMPARATOR | Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| Name | Type | Description |
|---|---|---|
| bimatoprost formulation A solution | DRUG | Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| bimatoprost solution 0.03 % | DRUG | Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| vehicle of bimatoprost formulation A solution | DRUG | Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| vehicle of bimatoprost solution 0.03 % | DRUG | Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
Inclusion Criteria: -Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth). Exclusion Criteria: * Damage to eyelid area (scarring) that may prevent growth of eyelashes * Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye) ...