Hypotrichosis
Conditions
Brief summary
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.
Interventions
One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have inadequate eyelashes * Never used prescription eyelash growth products
Exclusion criteria
* No visible eyelashes * Permanent eyeliner or eyelash implants * Semi-permanent eyelash tint, dye, or extensions within 3 months * Over-the-counter eyelash growth products within 6 months * Any disease, infection or abnormality of the eye or area around the eye * Eye surgery within 3 months, or the anticipated need for eye surgery during the study * Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall | Week 16 | Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score | Baseline, Week 16 | The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Ophthalmic Solution 0.03% One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. | 44 |
| Bimatoprost Vehicle Solution One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. | 44 |
| Total | 88 |
Baseline characteristics
| Characteristic | Bimatoprost Ophthalmic Solution 0.03% | Bimatoprost Vehicle Solution | Total |
|---|---|---|---|
| Age Continuous | 49.2 Years STANDARD_DEVIATION 12.6 | 50.2 Years STANDARD_DEVIATION 10.5 | 49.7 Years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 44 Participants | 44 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 44 | 3 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.
Time frame: Week 16
Population: Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost Ophthalmic Solution 0.03% | Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall | 67.4 Percentage of participants |
| Bimatoprost Vehicle Solution | Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall | 7.1 Percentage of participants |
Secondary
Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score
The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.
Time frame: Baseline, Week 16
Population: Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Bimatoprost Ophthalmic Solution 0.03% | Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score | 72.1 Percentage of participants | 0.37 |
| Bimatoprost Vehicle Solution | Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score | 19.0 Percentage of participants | 0.43 |