Alopecia, Alopecia, Androgenetic, Baldness
Conditions
Brief summary
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).
Interventions
DRUGBimatoprost Solution 1
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
DRUGBimatoprost Solution 2
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year * Willingness to maintain same hair style, length and hair color during study * Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)
Exclusion criteria
* Drug or alcohol abuse within 12 months * HIV positive * Received hair transplants or had scalp reductions * Use of hair weaves, hair extensions or wigs within 3 months * Use of minoxidil (oral or topical) and/or low level light treatment combs for hair growth within the last 6 months, or expected use during the study * Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Target Area Hair Count (TAHC) | Baseline, Month 6 | TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs). |
| Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Month 6 | The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Month 6 | The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. |
| Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Month 6 | At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. |
| Change From Baseline in Target Area Hair Width (TAHW) | Baseline, Month 6 | Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm\^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs). |
| Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline, Month 6 | Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stage 1: Bimatoprost Solution 1 Twice Daily Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. | 13 |
| Stage 1: Bimatoprost Solution 1 Once Daily Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. | 13 |
| Stage 1: Bimatoprost Solution 2 Twice Daily Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. | 12 |
| Stage 1: Bimatoprost Solution 2 Once Daily Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. | 12 |
| Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. | 65 |
| Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. | 65 |
| Stage 2: Bimatoprost Vehicle Twice Daily Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months. | 64 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 3 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 3 | 1 |
| Overall Study | Other Reasons | 0 | 0 | 1 | 1 | 2 | 2 | 2 |
| Overall Study | Personal Reasons | 0 | 0 | 0 | 0 | 2 | 3 | 3 |
Baseline characteristics
| Characteristic | Stage 1: Bimatoprost Solution 1 Twice Daily | Stage 1: Bimatoprost Solution 1 Once Daily | Stage 1: Bimatoprost Solution 2 Twice Daily | Stage 1: Bimatoprost Solution 2 Once Daily | Stage 2: Bimatoprost Solution 2 Twice Daily | Stage 2: Bimatoprost Solution 1 Twice Daily | Stage 2: Bimatoprost Vehicle Twice Daily | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Customized ≥18 to <35 years | 8 Participants | 0 Participants | 3 Participants | 3 Participants | 17 Participants | 18 Participants | 17 Participants | 66 Participants |
| Age, Customized 35 to 49 years | 5 Participants | 13 Participants | 9 Participants | 9 Participants | 48 Participants | 47 Participants | 47 Participants | 178 Participants |
| Sex/Gender, Customized Male | 13 Participants | 13 Participants | 12 Participants | 12 Participants | 65 Participants | 65 Participants | 64 Participants | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 13 | 4 / 13 | 7 / 12 | 1 / 12 | 25 / 65 | 25 / 65 | 7 / 64 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 | 0 / 12 | 0 / 12 | 1 / 65 | 2 / 65 | 0 / 64 |
Outcome results
Primary
Change From Baseline in Target Area Hair Count (TAHC)
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Time frame: Baseline, Month 6
Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2: Bimatoprost Solution 2 Twice Daily | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 131.3 terminal hairs/cm2 | Standard Deviation 55.53 |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 9.3 terminal hairs/cm2 | Standard Deviation 23.09 |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 140.4 terminal hairs/cm2 | Standard Deviation 59.76 |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 12.7 terminal hairs/cm2 | Standard Deviation 26.39 |
| Stage 2: Bimatoprost Vehicle Twice Daily | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 129.0 terminal hairs/cm2 | Standard Deviation 57.42 |
| Stage 2: Bimatoprost Vehicle Twice Daily | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 5.8 terminal hairs/cm2 | Standard Deviation 20.95 |
Primary
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time frame: Month 6
Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately increased | 25.4 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly decreased | 12.7 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the same | 23.8 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly increased | 4.8 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly increased | 33.3 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the same | 30.6 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly increased | 6.5 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately increased | 14.5 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly increased | 33.9 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly decreased | 12.9 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately decreased | 1.6 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly decreased | 30.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately increased | 6.7 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly decreased | 1.7 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately decreased | 6.7 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the same | 35.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly increased | 20.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly increased | 0.0 Percentage of Participants |
Secondary
Change From Baseline in Target Area Hair Darkness (TAHD)
Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).
Time frame: Baseline, Month 6
Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2: Bimatoprost Solution 2 Twice Daily | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 113.77 Intensity Units | Standard Deviation 19.458 |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | -1.63 Intensity Units | Standard Deviation 17.896 |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 115.76 Intensity Units | Standard Deviation 20.014 |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | -6.31 Intensity Units | Standard Deviation 17.016 |
| Stage 2: Bimatoprost Vehicle Twice Daily | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 115.22 Intensity Units | Standard Deviation 19.879 |
| Stage 2: Bimatoprost Vehicle Twice Daily | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | -1.62 Intensity Units | Standard Deviation 16.763 |
Secondary
Change From Baseline in Target Area Hair Width (TAHW)
Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm\^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).
Time frame: Baseline, Month 6
Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2: Bimatoprost Solution 2 Twice Daily | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 7.32 mm/cm2 | Standard Deviation 3.472 |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline at Month 6 | 0.67 mm/cm2 | Standard Deviation 1.185 |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 7.82 mm/cm2 | Standard Deviation 3.764 |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline at Month 6 | 0.92 mm/cm2 | Standard Deviation 1.435 |
| Stage 2: Bimatoprost Vehicle Twice Daily | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 7.30 mm/cm2 | Standard Deviation 3.55 |
| Stage 2: Bimatoprost Vehicle Twice Daily | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline at Month 6 | 0.05 mm/cm2 | Standard Deviation 1.018 |
Secondary
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time frame: Month 6
Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately increased | 9.7 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly decreased | 3.2 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the same | 45.2 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly increased | 1.6 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly increased | 40.3 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the same | 43.3 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly increased | 3.3 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately increased | 15.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly increased | 35.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly decreased | 3.3 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly decreased | 10.3 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately increased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately decreased | 1.7 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the same | 72.4 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly increased | 15.5 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly increased | 0.0 Percentage of Participants |
Secondary
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time frame: Month 6
Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately increased | 22.2 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly decreased | 3.2 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the same | 36.5 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly increased | 4.8 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 2 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly increased | 33.3 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the same | 41.9 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly increased | 11.3 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately increased | 17.7 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly increased | 25.8 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly decreased | 3.2 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Solution 1 Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly decreased | 13.3 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately increased | 3.3 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately decreased | 0.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the same | 60.0 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly increased | 23.3 Percentage of Participants |
| Stage 2: Bimatoprost Vehicle Twice Daily | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly increased | 0.0 Percentage of Participants |