Trial Outcomes & Findings for A Study to Evaluate the Efficacy of Investigational OTC Eye Drops (NCT NCT03198000)

NCT ID: NCT03198000

Last Updated: 2023-05-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: Baseline to 60 seconds after first product application
• Results posted on: 2023-05-24

Participant Flow

Participant milestones

Measure	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%	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%	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%
Overall Study STARTED	41	38	41
Overall Study COMPLETED	41	38	41
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intent-to-treat set

Baseline characteristics by cohort

Measure	F#13418-148/F#13418-158 n=41 Participants 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%	F#13418-148/F#PF004390 n=38 Participants Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05%	F#13418-158/F#PF004390 n=41 Participants 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%	Total n=120 Participants Total of all reporting groups
Age, Continuous	55.4 Years STANDARD_DEVIATION 15.58 • n=5 Participants • Intent-to-treat set	59.1 Years STANDARD_DEVIATION 13.85 • n=7 Participants • Intent-to-treat set	54.9 Years STANDARD_DEVIATION 12.47 • n=5 Participants • Intent-to-treat set	56.4 Years STANDARD_DEVIATION 14.03 • n=4 Participants • Intent-to-treat set
Sex: Female, Male Female	27 Participants n=5 Participants • Intent-to-treat set	22 Participants n=7 Participants • Intent-to-treat set	26 Participants n=5 Participants • Intent-to-treat set	75 Participants n=4 Participants • Intent-to-treat set
Sex: Female, Male Male	14 Participants n=5 Participants • Intent-to-treat set	16 Participants n=7 Participants • Intent-to-treat set	15 Participants n=5 Participants • Intent-to-treat set	45 Participants n=4 Participants • Intent-to-treat set
Race/Ethnicity, Customized White	36 Participants n=5 Participants • Intent-to-treat set	36 Participants n=7 Participants • Intent-to-treat set	39 Participants n=5 Participants • Intent-to-treat set	111 Participants n=4 Participants • Intent-to-treat set
Race/Ethnicity, Customized Black or African-American	3 Participants n=5 Participants • Intent-to-treat set	1 Participants n=7 Participants • Intent-to-treat set	0 Participants n=5 Participants • Intent-to-treat set	4 Participants n=4 Participants • Intent-to-treat set
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants • Intent-to-treat set	0 Participants n=7 Participants • Intent-to-treat set	1 Participants n=5 Participants • Intent-to-treat set	2 Participants n=4 Participants • Intent-to-treat set
Race/Ethnicity, Customized Other	1 Participants n=5 Participants • Intent-to-treat set	1 Participants n=7 Participants • Intent-to-treat set	1 Participants n=5 Participants • Intent-to-treat set	3 Participants n=4 Participants • Intent-to-treat set
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants • Intent-to-treat set	3 Participants n=7 Participants • Intent-to-treat set	7 Participants n=5 Participants • Intent-to-treat set	11 Participants n=4 Participants • Intent-to-treat set
Race/Ethnicity, Customized Not Hispanic or Latino	40 Participants n=5 Participants • Intent-to-treat set	35 Participants n=7 Participants • Intent-to-treat set	34 Participants n=5 Participants • Intent-to-treat set	109 Participants n=4 Participants • Intent-to-treat set
Region of Enrollment United States	41 Participants n=5 Participants • Intent-to-treat set	38 Participants n=7 Participants • Intent-to-treat set	41 Participants n=5 Participants • Intent-to-treat set	120 Participants n=4 Participants • Intent-to-treat set

PRIMARY outcome

Timeframe: Baseline to 60 seconds after first product application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application	0.31 units on a scale Standard Error 0.050	0.27 units on a scale Standard Error 0.050	0.32 units on a scale Standard Error 0.049

PRIMARY outcome

Timeframe: Baseline to 60 seconds after first product application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
Percentage of Participants With Response to Redness at 60 Seconds After First Product Application	53.6 Percentage	50.1 Percentage	50.1 Percentage

SECONDARY outcome

Timeframe: Baseline to 30 seconds after first product application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
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	0.09 units on a scale Standard Error 0.046	0.11 units on a scale Standard Error 0.046

SECONDARY outcome

Timeframe: Baseline to 2 minutes after first product application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
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	0.80 units on a scale Standard Error 0.048	0.83 units on a scale Standard Error 0.048

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
Clinician Assessment of Baseline Redness	1.64 units on a scale Standard Deviation 0.537	1.66 units on a scale Standard Deviation 0.497	1.76 units on a scale Standard Deviation 0.498

SECONDARY outcome

Timeframe: Baseline to 60 seconds after first product application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application	-1.4 units on a scale Standard Error 0.21	-1.1 units on a scale Standard Error 0.21	-1.2 units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline to 10 hours after first product application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
Change From Baseline in Ocular Comfort at 10 Hours After First Product Application	-1.4 units on a scale Standard Error 0.20	-1.7 units on a scale Standard Error 0.20	-1.6 units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline to 12 hours after first product application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
Change From Baseline in Ocular Comfort at 12 Hours After First Product Application	-1.4 units on a scale Standard Error 0.20	-1.5 units on a scale Standard Error 0.20	-1.6 units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Hydrated - Baseline Strongly agree (5)	8.9 Percentage of participants	10.1 Percentage of participants	8.5 Percentage of participants
My Eye Feels Hydrated - Baseline Somewhat agree (4)	30.4 Percentage of participants	34.2 Percentage of participants	28.0 Percentage of participants
My Eye Feels Hydrated - Baseline Neither agree or disagree (3)	10.1 Percentage of participants	12.7 Percentage of participants	9.8 Percentage of participants
My Eye Feels Hydrated - Baseline Somewhat disagree (2)	30.4 Percentage of participants	30.4 Percentage of participants	34.1 Percentage of participants
My Eye Feels Hydrated - Baseline Strongly disagree (1)	17.7 Percentage of participants	10.1 Percentage of participants	19.5 Percentage of participants
My Eye Feels Hydrated - Baseline No opinion	2.5 Percentage of participants	2.5 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 2 minutes after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Hydrated - 2 Minutes After First Application Strongly agree (5)	45.6 Percentage of participants	39.2 Percentage of participants	43.9 Percentage of participants
My Eye Feels Hydrated - 2 Minutes After First Application Somewhat agree (4)	48.1 Percentage of participants	49.4 Percentage of participants	42.7 Percentage of participants
My Eye Feels Hydrated - 2 Minutes After First Application Neither agree or disagree (3)	3.8 Percentage of participants	3.8 Percentage of participants	7.3 Percentage of participants
My Eye Feels Hydrated - 2 Minutes After First Application Somewhat disagree (2)	1.3 Percentage of participants	6.3 Percentage of participants	6.1 Percentage of participants
My Eye Feels Hydrated - 2 Minutes After First Application Strongly disagree (1)	1.3 Percentage of participants	1.3 Percentage of participants	0 Percentage of participants
My Eye Feels Hydrated - 2 Minutes After First Application No opinion	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 10 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Hydrated - 10 Hours After First Application Strongly agree (5)	31.6 Percentage of participants	43.0 Percentage of participants	29.3 Percentage of participants
My Eye Feels Hydrated - 10 Hours After First Application Somewhat agree (4)	41.8 Percentage of participants	35.4 Percentage of participants	41.5 Percentage of participants
My Eye Feels Hydrated - 10 Hours After First Application Neither agree or disagree (3)	10.1 Percentage of participants	8.9 Percentage of participants	11.0 Percentage of participants
My Eye Feels Hydrated - 10 Hours After First Application Somewhat disagree (2)	11.4 Percentage of participants	8.9 Percentage of participants	13.4 Percentage of participants
My Eye Feels Hydrated - 10 Hours After First Application Strongly disagree (1)	2.5 Percentage of participants	2.5 Percentage of participants	4.9 Percentage of participants
My Eye Feels Hydrated - 10 Hours After First Application No opinion	1.3 Percentage of participants	1.3 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 12 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Hydrated - 12 Hours After First Application Strongly agree (5)	36.7 Percentage of participants	35.4 Percentage of participants	30.5 Percentage of participants
My Eye Feels Hydrated - 12 Hours After First Application Somewhat agree (4)	43.0 Percentage of participants	40.5 Percentage of participants	41.5 Percentage of participants
My Eye Feels Hydrated - 12 Hours After First Application Neither agree or disagree (3)	3.8 Percentage of participants	6.3 Percentage of participants	7.3 Percentage of participants
My Eye Feels Hydrated - 12 Hours After First Application Somewhat disagree (2)	12.7 Percentage of participants	8.9 Percentage of participants	17.1 Percentage of participants
My Eye Feels Hydrated - 12 Hours After First Application Strongly disagree (1)	2.5 Percentage of participants	6.3 Percentage of participants	3.7 Percentage of participants
My Eye Feels Hydrated - 12 Hours After First Application No opinion	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 2 minutes after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Refreshed - 2 Minutes After First Application Strongly agree (5)	38.0 Percentage of participants	36.7 Percentage of participants	42.7 Percentage of participants
My Eye Feels Refreshed - 2 Minutes After First Application Somewhat agree (4)	46.8 Percentage of participants	44.3 Percentage of participants	36.6 Percentage of participants
My Eye Feels Refreshed - 2 Minutes After First Application Neither agree or disagree (3)	7.6 Percentage of participants	10.1 Percentage of participants	14.6 Percentage of participants
My Eye Feels Refreshed - 2 Minutes After First Application Somewhat disagree (2)	6.3 Percentage of participants	8.9 Percentage of participants	4.9 Percentage of participants
My Eye Feels Refreshed - 2 Minutes After First Application Strongly disagree (1)	1.3 Percentage of participants	0 Percentage of participants	1.2 Percentage of participants
My Eye Feels Refreshed - 2 Minutes After First Application No opinion	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 10 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Refreshed - 10 Hours After First Application Strongly agree (5)	32.9 Percentage of participants	34.2 Percentage of participants	32.9 Percentage of participants
My Eye Feels Refreshed - 10 Hours After First Application Somewhat agree (4)	36.7 Percentage of participants	45.6 Percentage of participants	43.9 Percentage of participants
My Eye Feels Refreshed - 10 Hours After First Application Neither agree or disagree (3)	13.9 Percentage of participants	3.8 Percentage of participants	6.1 Percentage of participants
My Eye Feels Refreshed - 10 Hours After First Application Somewhat disagree (2)	13.9 Percentage of participants	15.2 Percentage of participants	9.8 Percentage of participants
My Eye Feels Refreshed - 10 Hours After First Application Strongly disagree (1)	1.3 Percentage of participants	1.3 Percentage of participants	7.3 Percentage of participants
My Eye Feels Refreshed - 10 Hours After First Application No opinion	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 12 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Refreshed - 12 Hours After First Application Strongly agree (5)	27.8 Percentage of participants	30.4 Percentage of participants	26.8 Percentage of participants
My Eye Feels Refreshed - 12 Hours After First Application Somewhat agree (4)	38.0 Percentage of participants	36.7 Percentage of participants	37.8 Percentage of participants
My Eye Feels Refreshed - 12 Hours After First Application Neither agree or disagree (3)	16.5 Percentage of participants	12.7 Percentage of participants	14.6 Percentage of participants
My Eye Feels Refreshed - 12 Hours After First Application Somewhat disagree (2)	11.4 Percentage of participants	12.7 Percentage of participants	12.2 Percentage of participants
My Eye Feels Refreshed - 12 Hours After First Application Strongly disagree (1)	3.8 Percentage of participants	5.1 Percentage of participants	8.5 Percentage of participants
My Eye Feels Refreshed - 12 Hours After First Application No opinion	0 Percentage of participants	1.3 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline Strongly agree (5)	43.0 Percentage of participants	30.4 Percentage of participants	30.5 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline Somewhat agree (4)	25.3 Percentage of participants	31.6 Percentage of participants	26.8 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline Neither agree or disagree (3)	20.3 Percentage of participants	20.3 Percentage of participants	23.2 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline Somewhat disagree (2)	1.3 Percentage of participants	5.1 Percentage of participants	8.5 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline Strongly disagree (1)	2.5 Percentage of participants	3.8 Percentage of participants	7.3 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline No opinion	7.6 Percentage of participants	8.9 Percentage of participants	3.7 Percentage of participants

SECONDARY outcome

Timeframe: 2 minutes after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application Strongly agree (5)	46.8 Percentage of participants	39.2 Percentage of participants	37.8 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application Somewhat agree (4)	24.1 Percentage of participants	32.9 Percentage of participants	36.6 Percentage of participants
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	11.4 Percentage of participants	15.9 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application Somewhat disagree (2)	1.3 Percentage of participants	3.8 Percentage of participants	2.4 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application Strongly disagree (1)	1.3 Percentage of participants	2.5 Percentage of participants	4.9 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application No opinion	6.3 Percentage of participants	10.1 Percentage of participants	2.4 Percentage of participants

SECONDARY outcome

Timeframe: 10 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application Strongly agree (5)	46.8 Percentage of participants	51.9 Percentage of participants	46.3 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application Somewhat agree (4)	29.1 Percentage of participants	26.6 Percentage of participants	28.0 Percentage of participants
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	8.9 Percentage of participants	14.6 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application Somewhat disagree (2)	6.3 Percentage of participants	6.3 Percentage of participants	4.9 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application Strongly disagree (1)	0 Percentage of participants	1.3 Percentage of participants	2.4 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application No opinion	6.3 Percentage of participants	5.1 Percentage of participants	3.7 Percentage of participants

SECONDARY outcome

Timeframe: 12 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application Strongly agree (5)	38.0 Percentage of participants	38.0 Percentage of participants	30.5 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application Somewhat agree (4)	36.7 Percentage of participants	32.9 Percentage of participants	37.8 Percentage of participants
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	13.9 Percentage of participants	18.3 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application Somewhat disagree (2)	1.3 Percentage of participants	1.3 Percentage of participants	3.7 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application Strongly disagree (1)	0 Percentage of participants	5.1 Percentage of participants	3.7 Percentage of participants
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application No opinion	7.6 Percentage of participants	7.6 Percentage of participants	6.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
The Appearance of my Eye Can Show How I Really Feel - Baseline Strongly agree (5)	34.2 Percentage of participants	29.1 Percentage of participants	25.6 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - Baseline Somewhat agree (4)	36.7 Percentage of participants	40.5 Percentage of participants	37.8 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - Baseline Neither agree or disagree (3)	15.2 Percentage of participants	16.5 Percentage of participants	18.3 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - Baseline Somewhat disagree (2)	3.8 Percentage of participants	2.5 Percentage of participants	9.8 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - Baseline Strongly disagree (1)	1.3 Percentage of participants	3.8 Percentage of participants	3.7 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - Baseline No opinion	8.9 Percentage of participants	7.6 Percentage of participants	4.9 Percentage of participants

SECONDARY outcome

Timeframe: 2 minutes after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application Strongly agree (5)	36.7 Percentage of participants	34.2 Percentage of participants	35.4 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application Somewhat agree (4)	34.2 Percentage of participants	43.0 Percentage of participants	40.2 Percentage of participants
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	12.7 Percentage of participants	14.6 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application Somewhat disagree (2)	3.8 Percentage of participants	6.3 Percentage of participants	2.4 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application Strongly disagree (1)	1.3 Percentage of participants	0 Percentage of participants	2.4 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application No opinion	5.1 Percentage of participants	3.8 Percentage of participants	4.9 Percentage of participants

SECONDARY outcome

Timeframe: 10 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application Strongly agree (5)	35.4 Percentage of participants	31.6 Percentage of participants	32.9 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application Somewhat agree (4)	31.6 Percentage of participants	36.7 Percentage of participants	31.7 Percentage of participants
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	22.8 Percentage of participants	24.4 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application Somewhat disagree (2)	2.5 Percentage of participants	2.5 Percentage of participants	1.2 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application Strongly disagree (1)	0 Percentage of participants	1.3 Percentage of participants	2.4 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application No opinion	8.9 Percentage of participants	5.1 Percentage of participants	7.3 Percentage of participants

SECONDARY outcome

Timeframe: 12 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application Strongly agree (5)	34.2 Percentage of participants	35.4 Percentage of participants	32.9 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application Somewhat agree (4)	38.0 Percentage of participants	36.7 Percentage of participants	40.2 Percentage of participants
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	15.2 Percentage of participants	18.3 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application Somewhat disagree (2)	3.8 Percentage of participants	2.5 Percentage of participants	3.7 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application Strongly disagree (1)	0 Percentage of participants	1.3 Percentage of participants	1.2 Percentage of participants
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application No opinion	5.1 Percentage of participants	6.3 Percentage of participants	3.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Appears Healthy - Baseline Strongly agree (5)	40.5 Percentage of participants	41.8 Percentage of participants	45.1 Percentage of participants
My Eye Appears Healthy - Baseline Somewhat agree (4)	35.4 Percentage of participants	31.6 Percentage of participants	25.6 Percentage of participants
My Eye Appears Healthy - Baseline Neither agree or disagree (3)	10.1 Percentage of participants	15.2 Percentage of participants	8.5 Percentage of participants
My Eye Appears Healthy - Baseline Somewhat disagree (2)	5.1 Percentage of participants	6.3 Percentage of participants	11.0 Percentage of participants
My Eye Appears Healthy - Baseline Strongly disagree (1)	6.3 Percentage of participants	3.8 Percentage of participants	7.3 Percentage of participants
My Eye Appears Healthy - Baseline No opinion	2.5 Percentage of participants	1.3 Percentage of participants	2.4 Percentage of participants

SECONDARY outcome

Timeframe: 2 minutes after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Appears Healthy - 2 Minutes After First Application Strongly agree (5)	46.8 Percentage of participants	44.3 Percentage of participants	42.7 Percentage of participants
My Eye Appears Healthy - 2 Minutes After First Application Somewhat agree (4)	40.5 Percentage of participants	34.2 Percentage of participants	37.8 Percentage of participants
My Eye Appears Healthy - 2 Minutes After First Application Neither agree or disagree (3)	8.9 Percentage of participants	13.9 Percentage of participants	13.4 Percentage of participants
My Eye Appears Healthy - 2 Minutes After First Application Somewhat disagree (2)	1.3 Percentage of participants	5.1 Percentage of participants	3.7 Percentage of participants
My Eye Appears Healthy - 2 Minutes After First Application Strongly disagree (1)	0 Percentage of participants	1.3 Percentage of participants	1.2 Percentage of participants
My Eye Appears Healthy - 2 Minutes After First Application No opinion	2.5 Percentage of participants	1.3 Percentage of participants	1.2 Percentage of participants

SECONDARY outcome

Timeframe: 10 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Appears Healthy - 10 Hours After First Application Strongly agree (5)	48.1 Percentage of participants	50.6 Percentage of participants	48.8 Percentage of participants
My Eye Appears Healthy - 10 Hours After First Application Somewhat agree (4)	29.1 Percentage of participants	27.8 Percentage of participants	28.0 Percentage of participants
My Eye Appears Healthy - 10 Hours After First Application Neither agree or disagree (3)	11.4 Percentage of participants	12.7 Percentage of participants	13.4 Percentage of participants
My Eye Appears Healthy - 10 Hours After First Application Somewhat disagree (2)	5.1 Percentage of participants	6.3 Percentage of participants	6.1 Percentage of participants
My Eye Appears Healthy - 10 Hours After First Application Strongly disagree (1)	0 Percentage of participants	0 Percentage of participants	1.2 Percentage of participants
My Eye Appears Healthy - 10 Hours After First Application No opinion	5.1 Percentage of participants	2.5 Percentage of participants	2.4 Percentage of participants

SECONDARY outcome

Timeframe: 12 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Appears Healthy - 12 Hours After First Application Strongly agree (5)	54.4 Percentage of participants	51.9 Percentage of participants	47.6 Percentage of participants
My Eye Appears Healthy - 12 Hours After First Application Somewhat agree (4)	29.1 Percentage of participants	22.8 Percentage of participants	28.0 Percentage of participants
My Eye Appears Healthy - 12 Hours After First Application Neither agree or disagree (3)	11.4 Percentage of participants	11.4 Percentage of participants	18.3 Percentage of participants
My Eye Appears Healthy - 12 Hours After First Application Somewhat disagree (2)	1.3 Percentage of participants	5.1 Percentage of participants	2.4 Percentage of participants
My Eye Appears Healthy - 12 Hours After First Application Strongly disagree (1)	0 Percentage of participants	1.3 Percentage of participants	0 Percentage of participants
My Eye Appears Healthy - 12 Hours After First Application No opinion	2.5 Percentage of participants	5.1 Percentage of participants	2.4 Percentage of participants

SECONDARY outcome

Timeframe: 2 minutes after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Cool - 2 Minutes After First Application Strongly agree (5)	29.1 Percentage of participants	20.3 Percentage of participants	29.3 Percentage of participants
My Eye Feels Cool - 2 Minutes After First Application Somewhat agree (4)	40.5 Percentage of participants	44.3 Percentage of participants	32.9 Percentage of participants
My Eye Feels Cool - 2 Minutes After First Application Neither agree or disagree (3)	24.1 Percentage of participants	24.1 Percentage of participants	25.6 Percentage of participants
My Eye Feels Cool - 2 Minutes After First Application Somewhat disagree (2)	6.3 Percentage of participants	7.6 Percentage of participants	8.5 Percentage of participants
My Eye Feels Cool - 2 Minutes After First Application Strongly disagree (1)	0 Percentage of participants	2.5 Percentage of participants	2.4 Percentage of participants
My Eye Feels Cool - 2 Minutes After First Application No opinion	0 Percentage of participants	1.3 Percentage of participants	1.2 Percentage of participants

SECONDARY outcome

Timeframe: 10 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Cool - 10 Hours After First Application Strongly agree (5)	24.1 Percentage of participants	20.3 Percentage of participants	13.4 Percentage of participants
My Eye Feels Cool - 10 Hours After First Application Somewhat agree (4)	29.1 Percentage of participants	36.7 Percentage of participants	34.1 Percentage of participants
My Eye Feels Cool - 10 Hours After First Application Neither agree or disagree (3)	21.5 Percentage of participants	25.3 Percentage of participants	23.2 Percentage of participants
My Eye Feels Cool - 10 Hours After First Application Somewhat disagree (2)	17.7 Percentage of participants	10.1 Percentage of participants	14.6 Percentage of participants
My Eye Feels Cool - 10 Hours After First Application Strongly disagree (1)	2.5 Percentage of participants	6.3 Percentage of participants	13.4 Percentage of participants
My Eye Feels Cool - 10 Hours After First Application No opinion	2.5 Percentage of participants	1.3 Percentage of participants	1.2 Percentage of participants

SECONDARY outcome

Timeframe: 12 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Feels Cool - 12 Hours After First Application Strongly agree (5)	20.3 Percentage of participants	22.8 Percentage of participants	17.1 Percentage of participants
My Eye Feels Cool - 12 Hours After First Application Somewhat agree (4)	29.1 Percentage of participants	27.8 Percentage of participants	29.3 Percentage of participants
My Eye Feels Cool - 12 Hours After First Application Neither agree or disagree (3)	31.6 Percentage of participants	30.4 Percentage of participants	24.4 Percentage of participants
My Eye Feels Cool - 12 Hours After First Application Somewhat disagree (2)	12.7 Percentage of participants	10.1 Percentage of participants	17.1 Percentage of participants
My Eye Feels Cool - 12 Hours After First Application Strongly disagree (1)	5.1 Percentage of participants	5.1 Percentage of participants	11.0 Percentage of participants
My Eye Feels Cool - 12 Hours After First Application No opinion	0 Percentage of participants	2.5 Percentage of participants	1.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Appears to Sparkle - Baseline Strongly agree (5)	3.8 Percentage of participants	6.3 Percentage of participants	9.8 Percentage of participants
My Eye Appears to Sparkle - Baseline Somewhat agree (4)	24.1 Percentage of participants	20.3 Percentage of participants	19.5 Percentage of participants
My Eye Appears to Sparkle - Baseline Neither agree or disagree (3)	34.2 Percentage of participants	38.0 Percentage of participants	35.4 Percentage of participants
My Eye Appears to Sparkle - Baseline Somewhat disagree (2)	11.4 Percentage of participants	8.9 Percentage of participants	7.3 Percentage of participants
My Eye Appears to Sparkle - Baseline Strongly disagree (1)	7.6 Percentage of participants	11.4 Percentage of participants	13.4 Percentage of participants
My Eye Appears to Sparkle - Baseline No opinion	19.0 Percentage of participants	15.2 Percentage of participants	14.6 Percentage of participants

SECONDARY outcome

Timeframe: 2 minutes after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Appears to Sparkle - 2 Minutes After First Application Strongly agree (5)	6.3 Percentage of participants	8.9 Percentage of participants	14.6 Percentage of participants
My Eye Appears to Sparkle - 2 Minutes After First Application Somewhat agree (4)	34.2 Percentage of participants	26.6 Percentage of participants	20.7 Percentage of participants
My Eye Appears to Sparkle - 2 Minutes After First Application Neither agree or disagree (3)	30.4 Percentage of participants	35.4 Percentage of participants	37.8 Percentage of participants
My Eye Appears to Sparkle - 2 Minutes After First Application Somewhat disagree (2)	5.1 Percentage of participants	6.3 Percentage of participants	4.9 Percentage of participants
My Eye Appears to Sparkle - 2 Minutes After First Application Strongly disagree (1)	3.8 Percentage of participants	7.6 Percentage of participants	8.5 Percentage of participants
My Eye Appears to Sparkle - 2 Minutes After First Application No opinion	20.3 Percentage of participants	15.2 Percentage of participants	13.4 Percentage of participants

SECONDARY outcome

Timeframe: 10 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Appears to Sparkle - 10 Hours After First Application Strongly agree (5)	19.0 Percentage of participants	15.2 Percentage of participants	17.1 Percentage of participants
My Eye Appears to Sparkle - 10 Hours After First Application Somewhat agree (4)	29.1 Percentage of participants	34.2 Percentage of participants	28.0 Percentage of participants
My Eye Appears to Sparkle - 10 Hours After First Application Neither agree or disagree (3)	27.8 Percentage of participants	31.6 Percentage of participants	29.3 Percentage of participants
My Eye Appears to Sparkle - 10 Hours After First Application Somewhat disagree (2)	10.1 Percentage of participants	2.5 Percentage of participants	7.3 Percentage of participants
My Eye Appears to Sparkle - 10 Hours After First Application Strongly disagree (1)	1.3 Percentage of participants	7.6 Percentage of participants	9.8 Percentage of participants
My Eye Appears to Sparkle - 10 Hours After First Application No opinion	11.4 Percentage of participants	8.9 Percentage of participants	8.5 Percentage of participants

SECONDARY outcome

Timeframe: 12 hours after first application

Population: Intent-to-treat set

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.

Outcome measures

Measure	F# PF004390 Eye Drops n=79 Eyes Active Comparator - Tetrahydrozoline 0.05%	F# 13418-148 Eye Drops n=79 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%	F#13418-158 Eye Drops n=82 Eyes Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
My Eye Appears to Sparkle - 12 Hours After First Application Strongly agree (5)	17.7 Percentage of participants	13.9 Percentage of participants	19.5 Percentage of participants
My Eye Appears to Sparkle - 12 Hours After First Application Somewhat agree (4)	29.1 Percentage of participants	25.3 Percentage of participants	24.4 Percentage of participants
My Eye Appears to Sparkle - 12 Hours After First Application Neither agree or disagree (3)	31.6 Percentage of participants	38.0 Percentage of participants	26.8 Percentage of participants
My Eye Appears to Sparkle - 12 Hours After First Application Somewhat disagree (2)	8.9 Percentage of participants	5.1 Percentage of participants	9.8 Percentage of participants
My Eye Appears to Sparkle - 12 Hours After First Application Strongly disagree (1)	2.5 Percentage of participants	7.6 Percentage of participants	11.0 Percentage of participants
My Eye Appears to Sparkle - 12 Hours After First Application No opinion	8.9 Percentage of participants	8.9 Percentage of participants	8.5 Percentage of participants

Adverse Events

F#13418-148/F#13418-158

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

F#13418-148/F#PF004390

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

F#13418-158/F#PF004390

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amisha Parikh-Das, PhD, MPH

Johnson & Johnson Consumer Inc.

Phone: (973) 255-8701

Email: AParikh1@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Prior to submission for publication, PI was to provide sponsor with ≥ 60 days for publication review. No publication that included sponsor confidential information was to be submitted without sponsor's prior written consent. If requested, the PI was to withhold publication for up to 60 additional days to allow for patent application filing.
• Publication restrictions are in place

Restriction type: OTHER