Ophthalmic Solutions
Conditions
Keywords
Eye Redness, Eye Comfort, Red Eyes
Brief summary
This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.
Detailed description
Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.
Interventions
DRUGF# 13418-148 Eye Drops
ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day
DRUGF#13418-158 Eye Drops
ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day
DRUGF# PF-004390 Eye Drops
Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day
Sponsors
Johnson & Johnson Consumer Inc. (J&JCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research 3. Male or female of any race or ethnicity, aged 18 years and older; 4. Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1); 5. Able to read and understand English; 6. Healthy subjects with redness in both eyes 7. History of topical ocular drugs or desire to use within the last 6 months; 8. Ocular health within normal limits, 9. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.
Exclusion criteria
1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates); 2. Known sensitivity, allergy or contraindications to any investigational product ingredient; 3. Females who are pregnant, planning to become pregnant or breastfeeding during the study; 4. Subjects who were previously screened and determined to be ineligible for the study; 5. Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation; 6. Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1); 7. Relative, partner or staff of any clinical research site personnel; 8. Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection; 9. Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy; 10. Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period; 11. Has a compromised immune system; 12. Has any acute or chronic, medical or psychiatric conditions 13. Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study; 14. Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study; 15. Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application | Baseline to 60 seconds after first product application | Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
| Percentage of Participants With Response to Redness at 60 Seconds After First Product Application | Baseline to 60 seconds after first product application | The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application | Baseline to 30 seconds after first product application | Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
| Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application | Baseline to 2 minutes after first product application | Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
| Clinician Assessment of Baseline Redness | Baseline | Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
| Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application | Baseline to 60 seconds after first product application | Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better. |
| Change From Baseline in Ocular Comfort at 10 Hours After First Product Application | Baseline to 10 hours after first product application | Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better. |
| Change From Baseline in Ocular Comfort at 12 Hours After First Product Application | Baseline to 12 hours after first product application | Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better. |
| My Eye Feels Hydrated - Baseline | Baseline | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Hydrated - 2 Minutes After First Application | 2 minutes after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Hydrated - 10 Hours After First Application | 10 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Hydrated - 12 Hours After First Application | 12 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Refreshed - 2 Minutes After First Application | 2 minutes after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Refreshed - 10 Hours After First Application | 10 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Refreshed - 12 Hours After First Application | 12 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Baseline | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | 2 minutes after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Appears Healthy - Baseline | Baseline | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | 12 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| The Appearance of my Eye Can Show How I Really Feel - Baseline | Baseline | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | 2 minutes after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | 10 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | 12 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Appears Healthy - 10 Hours After First Application | 10 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Appears Healthy - 12 Hours After First Application | 12 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Cool - 2 Minutes After First Application | 2 minutes after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Cool - 10 Hours After First Application | 10 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Feels Cool - 12 Hours After First Application | 12 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Appears to Sparkle - Baseline | Baseline | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Appears to Sparkle - 2 Minutes After First Application | 2 minutes after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Appears to Sparkle - 10 Hours After First Application | 10 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Appears to Sparkle - 12 Hours After First Application | 12 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | 10 hours after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
| My Eye Appears Healthy - 2 Minutes After First Application | 2 minutes after first application | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| F#13418-148/F#13418-158 Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0% | 41 |
| F#13418-148/F#PF004390 Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05% | 38 |
| F#13418-158/F#PF004390 Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05% | 41 |
| Total | 120 |
Baseline characteristics
| Characteristic | F#13418-148/F#13418-158 | F#13418-148/F#PF004390 | F#13418-158/F#PF004390 | Total |
|---|---|---|---|---|
| Age, Continuous | 55.4 Years STANDARD_DEVIATION 15.58 | 59.1 Years STANDARD_DEVIATION 13.85 | 54.9 Years STANDARD_DEVIATION 12.47 | 56.4 Years STANDARD_DEVIATION 14.03 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African-American | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 3 Participants | 7 Participants | 11 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 40 Participants | 35 Participants | 34 Participants | 109 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 36 Participants | 36 Participants | 39 Participants | 111 Participants |
| Region of Enrollment United States | 41 Participants | 38 Participants | 41 Participants | 120 Participants |
| Sex: Female, Male Female | 27 Participants | 22 Participants | 26 Participants | 75 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 15 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 38 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 38 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 38 | 0 / 41 |
Outcome results
Primary
Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Time frame: Baseline to 60 seconds after first product application
Population: Intent-to-treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F# PF004390 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application | 0.31 units on a scale | Standard Error 0.05 |
| F# 13418-148 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application | 0.27 units on a scale | Standard Error 0.05 |
| F#13418-158 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application | 0.32 units on a scale | Standard Error 0.049 |
p-value: 0.39295% CI: [-0.14, 0.055]ANCOVA
p-value: 0.82895% CI: [-0.086, 0.107]ANCOVA
Primary
Percentage of Participants With Response to Redness at 60 Seconds After First Product Application
The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Time frame: Baseline to 60 seconds after first product application
Population: Intent-to-treat set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| F# PF004390 Eye Drops | Percentage of Participants With Response to Redness at 60 Seconds After First Product Application | 53.6 Percentage |
| F# 13418-148 Eye Drops | Percentage of Participants With Response to Redness at 60 Seconds After First Product Application | 50.1 Percentage |
| F#13418-158 Eye Drops | Percentage of Participants With Response to Redness at 60 Seconds After First Product Application | 50.1 Percentage |
p-value: 0.57695% CI: [0.539, 1.411]GEE model
p-value: 0.54495% CI: [0.552, 1.368]GEE model
Secondary
Change From Baseline in Ocular Comfort at 10 Hours After First Product Application
Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
Time frame: Baseline to 10 hours after first product application
Population: Intent-to-treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F# PF004390 Eye Drops | Change From Baseline in Ocular Comfort at 10 Hours After First Product Application | -1.4 units on a scale | Standard Error 0.2 |
| F# 13418-148 Eye Drops | Change From Baseline in Ocular Comfort at 10 Hours After First Product Application | -1.7 units on a scale | Standard Error 0.2 |
| F#13418-158 Eye Drops | Change From Baseline in Ocular Comfort at 10 Hours After First Product Application | -1.6 units on a scale | Standard Error 0.2 |
p-value: 0.16295% CI: [-0.6, 0.1]ANCOVA
p-value: 0.23495% CI: [-0.55, 0.14]ANCOVA
Secondary
Change From Baseline in Ocular Comfort at 12 Hours After First Product Application
Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
Time frame: Baseline to 12 hours after first product application
Population: Intent-to-treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F# PF004390 Eye Drops | Change From Baseline in Ocular Comfort at 12 Hours After First Product Application | -1.4 units on a scale | Standard Error 0.2 |
| F# 13418-148 Eye Drops | Change From Baseline in Ocular Comfort at 12 Hours After First Product Application | -1.5 units on a scale | Standard Error 0.2 |
| F#13418-158 Eye Drops | Change From Baseline in Ocular Comfort at 12 Hours After First Product Application | -1.6 units on a scale | Standard Error 0.2 |
p-value: 0.39895% CI: [-0.48, 0.19]ANCOVA
p-value: 0.23395% CI: [-0.54, 0.13]ANCOVA
Secondary
Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application
Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
Time frame: Baseline to 60 seconds after first product application
Population: Intent-to-treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F# PF004390 Eye Drops | Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application | -1.4 units on a scale | Standard Error 0.21 |
| F# 13418-148 Eye Drops | Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application | -1.1 units on a scale | Standard Error 0.21 |
| F#13418-158 Eye Drops | Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application | -1.2 units on a scale | Standard Error 0.2 |
p-value: 0.08595% CI: [-0.05, 0.78]ANCOVA
p-value: 0.26995% CI: [-0.18, 0.64]ANCOVA
Secondary
Clinician Assessment of Baseline Redness
Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Time frame: Baseline
Population: Intent-to-treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F# PF004390 Eye Drops | Clinician Assessment of Baseline Redness | 1.64 units on a scale | Standard Deviation 0.537 |
| F# 13418-148 Eye Drops | Clinician Assessment of Baseline Redness | 1.66 units on a scale | Standard Deviation 0.497 |
| F#13418-158 Eye Drops | Clinician Assessment of Baseline Redness | 1.76 units on a scale | Standard Deviation 0.498 |
Secondary
Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Time frame: Baseline to 2 minutes after first product application
Population: Intent-to-treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F# PF004390 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application | 0.88 units on a scale | Standard Error 0.048 |
| F# 13418-148 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application | 0.80 units on a scale | Standard Error 0.048 |
| F#13418-158 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application | 0.83 units on a scale | Standard Error 0.048 |
p-value: 0.11795% CI: [-0.177, 0.02]ANCOVA
p-value: 0.25595% CI: [-0.153, 0.041]ANCOVA
Secondary
Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Time frame: Baseline to 30 seconds after first product application
Population: Intent-to-treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F# PF004390 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application | 0.10 units on a scale | Standard Error 0.046 |
| F# 13418-148 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application | 0.09 units on a scale | Standard Error 0.046 |
| F#13418-158 Eye Drops | Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application | 0.11 units on a scale | Standard Error 0.046 |
p-value: 0.89395% CI: [-0.085, 0.074]ANCOVA
p-value: 0.88695% CI: [-0.073, 0.084]ANCOVA
Secondary
My Eye Appears Healthy - 10 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 10 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Strongly agree (5) | 48.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Somewhat agree (4) | 29.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Neither agree or disagree (3) | 11.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Somewhat disagree (2) | 5.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | No opinion | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | No opinion | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Strongly agree (5) | 50.6 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Somewhat agree (4) | 27.8 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Neither agree or disagree (3) | 12.7 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Somewhat agree (4) | 28.0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Neither agree or disagree (3) | 13.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | No opinion | 2.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Somewhat disagree (2) | 6.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Strongly agree (5) | 48.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 10 Hours After First Application | Strongly disagree (1) | 1.2 Percentage of participants |
Secondary
My Eye Appears Healthy - 12 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 12 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Strongly agree (5) | 54.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Somewhat agree (4) | 29.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Neither agree or disagree (3) | 11.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Somewhat disagree (2) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | No opinion | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | No opinion | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Strongly agree (5) | 51.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Somewhat disagree (2) | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Somewhat agree (4) | 22.8 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Neither agree or disagree (3) | 11.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Somewhat agree (4) | 28.0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Neither agree or disagree (3) | 18.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | No opinion | 2.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Somewhat disagree (2) | 2.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Strongly agree (5) | 47.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 12 Hours After First Application | Strongly disagree (1) | 0 Percentage of participants |
Secondary
My Eye Appears Healthy - 2 Minutes After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 2 minutes after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Strongly agree (5) | 46.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Somewhat agree (4) | 40.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Neither agree or disagree (3) | 8.9 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Somewhat disagree (2) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | No opinion | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | No opinion | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Strongly agree (5) | 44.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Somewhat disagree (2) | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Somewhat agree (4) | 34.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Neither agree or disagree (3) | 13.9 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Somewhat agree (4) | 37.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Neither agree or disagree (3) | 13.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | No opinion | 1.2 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Somewhat disagree (2) | 3.7 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Strongly agree (5) | 42.7 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - 2 Minutes After First Application | Strongly disagree (1) | 1.2 Percentage of participants |
Secondary
My Eye Appears Healthy - Baseline
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: Baseline
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Appears Healthy - Baseline | Strongly disagree (1) | 6.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - Baseline | Neither agree or disagree (3) | 10.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - Baseline | Somewhat disagree (2) | 5.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - Baseline | No opinion | 2.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - Baseline | Somewhat agree (4) | 35.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears Healthy - Baseline | Strongly agree (5) | 40.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - Baseline | Neither agree or disagree (3) | 15.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - Baseline | Strongly agree (5) | 41.8 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - Baseline | Somewhat agree (4) | 31.6 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - Baseline | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - Baseline | Strongly disagree (1) | 3.8 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears Healthy - Baseline | No opinion | 1.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - Baseline | Somewhat agree (4) | 25.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - Baseline | No opinion | 2.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - Baseline | Strongly disagree (1) | 7.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - Baseline | Neither agree or disagree (3) | 8.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - Baseline | Strongly agree (5) | 45.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears Healthy - Baseline | Somewhat disagree (2) | 11.0 Percentage of participants |
Secondary
My Eye Appears to Sparkle - 10 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 10 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Strongly agree (5) | 19.0 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Somewhat agree (4) | 29.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Neither agree or disagree (3) | 27.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Somewhat disagree (2) | 10.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | No opinion | 11.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | No opinion | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Strongly agree (5) | 15.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Somewhat disagree (2) | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Strongly disagree (1) | 7.6 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Somewhat agree (4) | 34.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Neither agree or disagree (3) | 31.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Somewhat agree (4) | 28.0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Neither agree or disagree (3) | 29.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | No opinion | 8.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Somewhat disagree (2) | 7.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Strongly agree (5) | 17.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 10 Hours After First Application | Strongly disagree (1) | 9.8 Percentage of participants |
Secondary
My Eye Appears to Sparkle - 12 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 12 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Strongly agree (5) | 17.7 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Somewhat agree (4) | 29.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Neither agree or disagree (3) | 31.6 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Somewhat disagree (2) | 8.9 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Strongly disagree (1) | 2.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | No opinion | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | No opinion | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Strongly agree (5) | 13.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Somewhat disagree (2) | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Strongly disagree (1) | 7.6 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Somewhat agree (4) | 25.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Neither agree or disagree (3) | 38.0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Somewhat agree (4) | 24.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Neither agree or disagree (3) | 26.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | No opinion | 8.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Somewhat disagree (2) | 9.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Strongly agree (5) | 19.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 12 Hours After First Application | Strongly disagree (1) | 11.0 Percentage of participants |
Secondary
My Eye Appears to Sparkle - 2 Minutes After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 2 minutes after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Somewhat disagree (2) | 5.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Strongly disagree (1) | 3.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | No opinion | 20.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Strongly agree (5) | 6.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Somewhat agree (4) | 34.2 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Neither agree or disagree (3) | 30.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Neither agree or disagree (3) | 35.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Strongly agree (5) | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Somewhat agree (4) | 26.6 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Strongly disagree (1) | 7.6 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | No opinion | 15.2 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Strongly disagree (1) | 8.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | No opinion | 13.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Neither agree or disagree (3) | 37.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Strongly agree (5) | 14.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Somewhat disagree (2) | 4.9 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - 2 Minutes After First Application | Somewhat agree (4) | 20.7 Percentage of participants |
Secondary
My Eye Appears to Sparkle - Baseline
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: Baseline
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - Baseline | Strongly agree (5) | 3.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - Baseline | Somewhat agree (4) | 24.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - Baseline | Neither agree or disagree (3) | 34.2 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - Baseline | Somewhat disagree (2) | 11.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - Baseline | Strongly disagree (1) | 7.6 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Appears to Sparkle - Baseline | No opinion | 19.0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - Baseline | No opinion | 15.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - Baseline | Strongly agree (5) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - Baseline | Somewhat disagree (2) | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - Baseline | Strongly disagree (1) | 11.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - Baseline | Somewhat agree (4) | 20.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Appears to Sparkle - Baseline | Neither agree or disagree (3) | 38.0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - Baseline | Somewhat agree (4) | 19.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - Baseline | Neither agree or disagree (3) | 35.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - Baseline | No opinion | 14.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - Baseline | Somewhat disagree (2) | 7.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - Baseline | Strongly agree (5) | 9.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Appears to Sparkle - Baseline | Strongly disagree (1) | 13.4 Percentage of participants |
Secondary
My Eye Feels Cool - 10 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 10 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Strongly agree (5) | 24.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Somewhat agree (4) | 29.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Neither agree or disagree (3) | 21.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Somewhat disagree (2) | 17.7 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Strongly disagree (1) | 2.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | No opinion | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | No opinion | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Strongly agree (5) | 20.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Somewhat disagree (2) | 10.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Strongly disagree (1) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Somewhat agree (4) | 36.7 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Neither agree or disagree (3) | 25.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Somewhat agree (4) | 34.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Neither agree or disagree (3) | 23.2 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | No opinion | 1.2 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Somewhat disagree (2) | 14.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Strongly agree (5) | 13.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 10 Hours After First Application | Strongly disagree (1) | 13.4 Percentage of participants |
Secondary
My Eye Feels Cool - 12 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 12 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Strongly agree (5) | 20.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Somewhat agree (4) | 29.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Neither agree or disagree (3) | 31.6 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Somewhat disagree (2) | 12.7 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Strongly disagree (1) | 5.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | No opinion | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Strongly agree (5) | 22.8 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Somewhat disagree (2) | 10.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Strongly disagree (1) | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Somewhat agree (4) | 27.8 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Neither agree or disagree (3) | 30.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Somewhat agree (4) | 29.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Neither agree or disagree (3) | 24.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | No opinion | 1.2 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Somewhat disagree (2) | 17.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Strongly agree (5) | 17.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 12 Hours After First Application | Strongly disagree (1) | 11.0 Percentage of participants |
Secondary
My Eye Feels Cool - 2 Minutes After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 2 minutes after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Strongly agree (5) | 29.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Somewhat agree (4) | 40.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Neither agree or disagree (3) | 24.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | No opinion | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Strongly agree (5) | 20.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Somewhat disagree (2) | 7.6 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Strongly disagree (1) | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Somewhat agree (4) | 44.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Neither agree or disagree (3) | 24.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Somewhat agree (4) | 32.9 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Neither agree or disagree (3) | 25.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | No opinion | 1.2 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Somewhat disagree (2) | 8.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Strongly agree (5) | 29.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Cool - 2 Minutes After First Application | Strongly disagree (1) | 2.4 Percentage of participants |
Secondary
My Eye Feels Hydrated - 10 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 10 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Strongly agree (5) | 31.6 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Somewhat agree (4) | 41.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Neither agree or disagree (3) | 10.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Somewhat disagree (2) | 11.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Strongly disagree (1) | 2.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | No opinion | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | No opinion | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Strongly agree (5) | 43.0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Somewhat disagree (2) | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Strongly disagree (1) | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Somewhat agree (4) | 35.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Neither agree or disagree (3) | 8.9 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Somewhat agree (4) | 41.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Neither agree or disagree (3) | 11.0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | No opinion | 0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Somewhat disagree (2) | 13.4 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Strongly agree (5) | 29.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 10 Hours After First Application | Strongly disagree (1) | 4.9 Percentage of participants |
Secondary
My Eye Feels Hydrated - 12 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 12 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Strongly agree (5) | 36.7 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Somewhat agree (4) | 43.0 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Neither agree or disagree (3) | 3.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Somewhat disagree (2) | 12.7 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Strongly disagree (1) | 2.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Strongly agree (5) | 35.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Somewhat disagree (2) | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Strongly disagree (1) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Somewhat agree (4) | 40.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Neither agree or disagree (3) | 6.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Somewhat agree (4) | 41.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Neither agree or disagree (3) | 7.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | No opinion | 0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Somewhat disagree (2) | 17.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Strongly agree (5) | 30.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 12 Hours After First Application | Strongly disagree (1) | 3.7 Percentage of participants |
Secondary
My Eye Feels Hydrated - 2 Minutes After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 2 minutes after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Strongly agree (5) | 45.6 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Somewhat agree (4) | 48.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Neither agree or disagree (3) | 3.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Somewhat disagree (2) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Strongly agree (5) | 39.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Somewhat agree (4) | 49.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Neither agree or disagree (3) | 3.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Somewhat agree (4) | 42.7 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Neither agree or disagree (3) | 7.3 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | No opinion | 0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Somewhat disagree (2) | 6.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Strongly agree (5) | 43.9 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - 2 Minutes After First Application | Strongly disagree (1) | 0 Percentage of participants |
Secondary
My Eye Feels Hydrated - Baseline
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: Baseline
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Hydrated - Baseline | Strongly agree (5) | 8.9 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - Baseline | Somewhat agree (4) | 30.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - Baseline | Neither agree or disagree (3) | 10.1 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - Baseline | Somewhat disagree (2) | 30.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - Baseline | Strongly disagree (1) | 17.7 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Hydrated - Baseline | No opinion | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - Baseline | No opinion | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - Baseline | Strongly agree (5) | 10.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - Baseline | Somewhat disagree (2) | 30.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - Baseline | Strongly disagree (1) | 10.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - Baseline | Somewhat agree (4) | 34.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Hydrated - Baseline | Neither agree or disagree (3) | 12.7 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - Baseline | Somewhat agree (4) | 28.0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - Baseline | Neither agree or disagree (3) | 9.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - Baseline | No opinion | 0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - Baseline | Somewhat disagree (2) | 34.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - Baseline | Strongly agree (5) | 8.5 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Hydrated - Baseline | Strongly disagree (1) | 19.5 Percentage of participants |
Secondary
My Eye Feels Refreshed - 10 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 10 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Strongly agree (5) | 32.9 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Somewhat agree (4) | 36.7 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Neither agree or disagree (3) | 13.9 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Somewhat disagree (2) | 13.9 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Strongly agree (5) | 34.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Somewhat disagree (2) | 15.2 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Somewhat agree (4) | 45.6 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Neither agree or disagree (3) | 3.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Somewhat agree (4) | 43.9 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Neither agree or disagree (3) | 6.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | No opinion | 0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Somewhat disagree (2) | 9.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Strongly agree (5) | 32.9 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 10 Hours After First Application | Strongly disagree (1) | 7.3 Percentage of participants |
Secondary
My Eye Feels Refreshed - 12 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 12 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Strongly agree (5) | 27.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Somewhat agree (4) | 38.0 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Neither agree or disagree (3) | 16.5 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Somewhat disagree (2) | 11.4 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Strongly disagree (1) | 3.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | No opinion | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Strongly agree (5) | 30.4 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Somewhat disagree (2) | 12.7 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Strongly disagree (1) | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Somewhat agree (4) | 36.7 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Neither agree or disagree (3) | 12.7 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Somewhat agree (4) | 37.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Neither agree or disagree (3) | 14.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | No opinion | 0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Somewhat disagree (2) | 12.2 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Strongly agree (5) | 26.8 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 12 Hours After First Application | Strongly disagree (1) | 8.5 Percentage of participants |
Secondary
My Eye Feels Refreshed - 2 Minutes After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 2 minutes after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Strongly agree (5) | 38.0 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Somewhat agree (4) | 46.8 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Neither agree or disagree (3) | 7.6 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | No opinion | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Strongly agree (5) | 36.7 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Somewhat disagree (2) | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Somewhat agree (4) | 44.3 Percentage of participants |
| F# 13418-148 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Neither agree or disagree (3) | 10.1 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Somewhat agree (4) | 36.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Neither agree or disagree (3) | 14.6 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | No opinion | 0 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Somewhat disagree (2) | 4.9 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Strongly agree (5) | 42.7 Percentage of participants |
| F#13418-158 Eye Drops | My Eye Feels Refreshed - 2 Minutes After First Application | Strongly disagree (1) | 1.2 Percentage of participants |
Secondary
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 10 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Strongly agree (5) | 35.4 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Somewhat agree (4) | 31.6 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Neither agree or disagree (3) | 20.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Somewhat disagree (2) | 2.5 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | No opinion | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | No opinion | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Strongly agree (5) | 31.6 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Somewhat disagree (2) | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Somewhat agree (4) | 36.7 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Neither agree or disagree (3) | 22.8 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Somewhat agree (4) | 31.7 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Neither agree or disagree (3) | 24.4 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | No opinion | 7.3 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Somewhat disagree (2) | 1.2 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Strongly agree (5) | 32.9 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application | Strongly disagree (1) | 2.4 Percentage of participants |
Secondary
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 12 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Strongly agree (5) | 34.2 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Somewhat agree (4) | 38.0 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Neither agree or disagree (3) | 17.7 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Somewhat disagree (2) | 3.8 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | No opinion | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | No opinion | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Strongly agree (5) | 35.4 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Somewhat disagree (2) | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Somewhat agree (4) | 36.7 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Neither agree or disagree (3) | 15.2 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Somewhat agree (4) | 40.2 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Neither agree or disagree (3) | 18.3 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | No opinion | 3.7 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Somewhat disagree (2) | 3.7 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Strongly agree (5) | 32.9 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application | Strongly disagree (1) | 1.2 Percentage of participants |
Secondary
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 2 minutes after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Strongly agree (5) | 36.7 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Somewhat agree (4) | 34.2 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Neither agree or disagree (3) | 19.0 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Somewhat disagree (2) | 3.8 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | No opinion | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | No opinion | 3.8 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Strongly agree (5) | 34.2 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Somewhat agree (4) | 43.0 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Neither agree or disagree (3) | 12.7 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Somewhat agree (4) | 40.2 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Neither agree or disagree (3) | 14.6 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | No opinion | 4.9 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Somewhat disagree (2) | 2.4 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Strongly agree (5) | 35.4 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application | Strongly disagree (1) | 2.4 Percentage of participants |
Secondary
The Appearance of my Eye Can Show How I Really Feel - Baseline
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: Baseline
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Strongly agree (5) | 34.2 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Somewhat agree (4) | 36.7 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Neither agree or disagree (3) | 15.2 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Somewhat disagree (2) | 3.8 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Strongly disagree (1) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | No opinion | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | No opinion | 7.6 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Strongly agree (5) | 29.1 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Somewhat disagree (2) | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Strongly disagree (1) | 3.8 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Somewhat agree (4) | 40.5 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Neither agree or disagree (3) | 16.5 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Somewhat agree (4) | 37.8 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Neither agree or disagree (3) | 18.3 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | No opinion | 4.9 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Somewhat disagree (2) | 9.8 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Strongly agree (5) | 25.6 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Can Show How I Really Feel - Baseline | Strongly disagree (1) | 3.7 Percentage of participants |
Secondary
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 10 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Strongly agree (5) | 46.8 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Somewhat agree (4) | 29.1 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Neither agree or disagree (3) | 10.1 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | No opinion | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | No opinion | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Strongly agree (5) | 51.9 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Somewhat disagree (2) | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Somewhat agree (4) | 26.6 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Neither agree or disagree (3) | 8.9 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Somewhat agree (4) | 28.0 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Neither agree or disagree (3) | 14.6 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | No opinion | 3.7 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Somewhat disagree (2) | 4.9 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Strongly agree (5) | 46.3 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application | Strongly disagree (1) | 2.4 Percentage of participants |
Secondary
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 12 hours after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Strongly agree (5) | 38.0 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Somewhat agree (4) | 36.7 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Neither agree or disagree (3) | 15.2 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Somewhat disagree (2) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Strongly disagree (1) | 0 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | No opinion | 7.6 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | No opinion | 7.6 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Strongly agree (5) | 38.0 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Somewhat disagree (2) | 1.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Strongly disagree (1) | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Somewhat agree (4) | 32.9 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Neither agree or disagree (3) | 13.9 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Somewhat agree (4) | 37.8 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Neither agree or disagree (3) | 18.3 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | No opinion | 6.1 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Somewhat disagree (2) | 3.7 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Strongly agree (5) | 30.5 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application | Strongly disagree (1) | 3.7 Percentage of participants |
Secondary
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: 2 minutes after first application
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Strongly agree (5) | 46.8 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Somewhat agree (4) | 24.1 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Neither agree or disagree (3) | 20.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Somewhat disagree (2) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Strongly disagree (1) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | No opinion | 6.3 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | No opinion | 10.1 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Strongly agree (5) | 39.2 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Somewhat disagree (2) | 3.8 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Strongly disagree (1) | 2.5 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Somewhat agree (4) | 32.9 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Neither agree or disagree (3) | 11.4 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Somewhat agree (4) | 36.6 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Neither agree or disagree (3) | 15.9 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | No opinion | 2.4 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Somewhat disagree (2) | 2.4 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Strongly agree (5) | 37.8 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application | Strongly disagree (1) | 4.9 Percentage of participants |
Secondary
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Time frame: Baseline
Population: Intent-to-treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Strongly agree (5) | 43.0 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Somewhat agree (4) | 25.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Neither agree or disagree (3) | 20.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Somewhat disagree (2) | 1.3 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Strongly disagree (1) | 2.5 Percentage of participants |
| F# PF004390 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | No opinion | 7.6 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | No opinion | 8.9 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Strongly agree (5) | 30.4 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Somewhat disagree (2) | 5.1 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Strongly disagree (1) | 3.8 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Somewhat agree (4) | 31.6 Percentage of participants |
| F# 13418-148 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Neither agree or disagree (3) | 20.3 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Somewhat agree (4) | 26.8 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Neither agree or disagree (3) | 23.2 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | No opinion | 3.7 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Somewhat disagree (2) | 8.5 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Strongly agree (5) | 30.5 Percentage of participants |
| F#13418-158 Eye Drops | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline | Strongly disagree (1) | 7.3 Percentage of participants |