CompletedNCT03198000Updated May 24, 2023Results posted

A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

A Phase 3 interventional study of F# 13418-148 Eye Drops and F#13418-158 Eye Drops in Ophthalmic Solutions, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 120
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Ophthalmic Solutions

Keywords

Eye Redness
Eye Comfort
Red Eyes

In context

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 52 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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;
Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
Male or female of any race or ethnicity, aged 18 years and older;
Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
Able to read and understand English;
Healthy subjects with redness in both eyes
History of topical ocular drugs or desire to use within the last 6 months;
Ocular health within normal limits,
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

Exclusion Criteria:

Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
Known sensitivity, allergy or contraindications to any investigational product ingredient;
Females who are pregnant, planning to become pregnant or breastfeeding during the study;
Subjects who were previously screened and determined to be ineligible for the study;
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;
Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
Relative, partner or staff of any clinical research site personnel;
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;
Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
Has a compromised immune system;
Has any acute or chronic, medical or psychiatric conditions
Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 120 participants (actual)

Study arms

Experimental
Formula # 13418-148
Drug: F# 13418-148 Eye Drops
Experimental
Formula # 13418-158
Drug: F#13418-158 Eye Drops
Active comparator
Control Formula # PF004390
Drug: F# PF-004390 Eye Drops

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

What researchers measure

Primary outcomes

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
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

Secondary outcomes

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Results

Posted Aug 8, 2018

Participant flow

Participant flow — Overall Study
Milestone	F#13418-148/F#13418-158	F#13418-148/F#PF004390	F#13418-158/F#PF004390
Started	41	38	41
Completed	41	38	41
Not completed	0	0	0

Outcome measures

PrimaryClinician 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
Reported as:: Mean · units on a scale

Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application
units on a scale	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application	0.31 ± 0.050	0.27 ± 0.050	0.32 ± 0.049

Statistical analysis

F# PF004390 Eye Drops vs F# 13418-148 Eye Drops · ANCOVA · p = 0.392 · Mean difference (final values): -0.04 · 95% CI -0.140 to 0.055Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.
F# PF004390 Eye Drops vs F#13418-158 Eye Drops · ANCOVA · p = 0.828 · Mean difference (final values): 0.01 · 95% CI -0.086 to 0.107Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.

PrimaryPercentage 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
Reported as:: Number · Percentage

Percentage of Participants With Response to Redness at 60 Seconds After First Product Application
Percentage	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Percentage of Participants With Response to Redness at 60 Seconds After First Product Application	53.6	50.1	50.1

Statistical analysis

F# PF004390 Eye Drops vs F# 13418-148 Eye Drops · GEE model · p = 0.576 · Odds ratio (or): 0.87 · 95% CI 0.539 to 1.411GEE model with treatment as factor.
F# PF004390 Eye Drops vs F#13418-158 Eye Drops · GEE model · p = 0.544 · Odds ratio (or): 0.87 · 95% CI 0.552 to 1.368GEE model with treatment as factor.

SecondaryClinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application

Time frame:: Baseline to 30 seconds after first product application
Reported as:: Mean · units on a scale

Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application
units on a scale	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application	0.10 ± 0.046	0.09 ± 0.046	0.11 ± 0.046

Statistical analysis

F# PF004390 Eye Drops vs F# 13418-148 Eye Drops · ANCOVA · p = 0.893 · Mean difference (final values): -0.01 · 95% CI -0.085 to 0.074Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.
F# PF004390 Eye Drops vs F#13418-158 Eye Drops · ANCOVA · p = 0.886 · Mean difference (final values): 0.01 · 95% CI -0.073 to 0.084Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.

SecondaryClinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application

Time frame:: Baseline to 2 minutes after first product application
Reported as:: Mean · units on a scale

Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application
units on a scale	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application	0.88 ± 0.048	0.80 ± 0.048	0.83 ± 0.048

Statistical analysis

F# PF004390 Eye Drops vs F# 13418-148 Eye Drops · ANCOVA · p = 0.117 · Mean difference (final values): -0.08 · 95% CI -0.177 to 0.020Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.
F# PF004390 Eye Drops vs F#13418-158 Eye Drops · ANCOVA · p = 0.255 · Mean difference (final values): -0.06 · 95% CI -0.153 to 0.041Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.

SecondaryClinician 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
Reported as:: Mean · units on a scale

Clinician Assessment of Baseline Redness
units on a scale	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Clinician Assessment of Baseline Redness	1.64 ± 0.537	1.66 ± 0.497	1.76 ± 0.498

SecondaryChange 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
Reported as:: Mean · units on a scale

Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application
units on a scale	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application	-1.4 ± 0.21	-1.1 ± 0.21	-1.2 ± 0.20

Statistical analysis

F# PF004390 Eye Drops vs F# 13418-148 Eye Drops · ANCOVA · p = 0.085 · Mean difference (final values): 0.4 · 95% CI -0.05 to 0.78Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.
F# PF004390 Eye Drops vs F#13418-158 Eye Drops · ANCOVA · p = 0.269 · Mean difference (final values): 0.2 · 95% CI -0.18 to 0.64Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.

SecondaryChange 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
Reported as:: Mean · units on a scale

Change From Baseline in Ocular Comfort at 10 Hours After First Product Application
units on a scale	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Change From Baseline in Ocular Comfort at 10 Hours After First Product Application	-1.4 ± 0.20	-1.7 ± 0.20	-1.6 ± 0.20

Statistical analysis

F# PF004390 Eye Drops vs F# 13418-148 Eye Drops · ANCOVA · p = 0.162 · Mean difference (final values): -0.2 · 95% CI -0.60 to 0.10Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.
F# PF004390 Eye Drops vs F#13418-158 Eye Drops · ANCOVA · p = 0.234 · Mean difference (final values): -0.2 · 95% CI -0.55 to 0.14Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.

SecondaryChange 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
Reported as:: Mean · units on a scale

Change From Baseline in Ocular Comfort at 12 Hours After First Product Application
units on a scale	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Change From Baseline in Ocular Comfort at 12 Hours After First Product Application	-1.4 ± 0.20	-1.5 ± 0.20	-1.6 ± 0.20

Statistical analysis

F# PF004390 Eye Drops vs F# 13418-148 Eye Drops · ANCOVA · p = 0.398 · Mean difference (final values): -0.1 · 95% CI -0.48 to 0.19Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.
F# PF004390 Eye Drops vs F#13418-158 Eye Drops · ANCOVA · p = 0.233 · Mean difference (final values): -0.2 · 95% CI -0.54 to 0.13Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.

SecondaryMy 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
Reported as:: Number · Percentage of participants

My Eye Feels Hydrated - Baseline
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	8.9	10.1	8.5
Somewhat agree (4)	30.4	34.2	28.0
Neither agree or disagree (3)	10.1	12.7	9.8
Somewhat disagree (2)	30.4	30.4	34.1
Strongly disagree (1)	17.7	10.1	19.5
No opinion	2.5	2.5	0

SecondaryMy Eye Feels Hydrated - 2 Minutes After First Application

Time frame:: 2 minutes after first application
Reported as:: Number · Percentage of participants

My Eye Feels Hydrated - 2 Minutes After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	45.6	39.2	43.9
Somewhat agree (4)	48.1	49.4	42.7
Neither agree or disagree (3)	3.8	3.8	7.3
Somewhat disagree (2)	1.3	6.3	6.1
Strongly disagree (1)	1.3	1.3	0
No opinion	0	0	0

SecondaryMy Eye Feels Hydrated - 10 Hours After First Application

Time frame:: 10 hours after first application
Reported as:: Number · Percentage of participants

My Eye Feels Hydrated - 10 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	31.6	43.0	29.3
Somewhat agree (4)	41.8	35.4	41.5
Neither agree or disagree (3)	10.1	8.9	11.0
Somewhat disagree (2)	11.4	8.9	13.4
Strongly disagree (1)	2.5	2.5	4.9
No opinion	1.3	1.3	0

SecondaryMy Eye Feels Hydrated - 12 Hours After First Application

Time frame:: 12 hours after first application
Reported as:: Number · Percentage of participants

My Eye Feels Hydrated - 12 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	36.7	35.4	30.5
Somewhat agree (4)	43.0	40.5	41.5
Neither agree or disagree (3)	3.8	6.3	7.3
Somewhat disagree (2)	12.7	8.9	17.1
Strongly disagree (1)	2.5	6.3	3.7
No opinion	0	0	0

SecondaryMy Eye Feels Refreshed - 2 Minutes After First Application

Time frame:: 2 minutes after first application
Reported as:: Number · Percentage of participants

My Eye Feels Refreshed - 2 Minutes After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	38.0	36.7	42.7
Somewhat agree (4)	46.8	44.3	36.6
Neither agree or disagree (3)	7.6	10.1	14.6
Somewhat disagree (2)	6.3	8.9	4.9
Strongly disagree (1)	1.3	0	1.2
No opinion	0	0	0

SecondaryMy Eye Feels Refreshed - 10 Hours After First Application

Time frame:: 10 hours after first application
Reported as:: Number · Percentage of participants

My Eye Feels Refreshed - 10 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	32.9	34.2	32.9
Somewhat agree (4)	36.7	45.6	43.9
Neither agree or disagree (3)	13.9	3.8	6.1
Somewhat disagree (2)	13.9	15.2	9.8
Strongly disagree (1)	1.3	1.3	7.3
No opinion	0	0	0

SecondaryMy Eye Feels Refreshed - 12 Hours After First Application

Time frame:: 12 hours after first application
Reported as:: Number · Percentage of participants

My Eye Feels Refreshed - 12 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	27.8	30.4	26.8
Somewhat agree (4)	38.0	36.7	37.8
Neither agree or disagree (3)	16.5	12.7	14.6
Somewhat disagree (2)	11.4	12.7	12.2
Strongly disagree (1)	3.8	5.1	8.5
No opinion	0	1.3	0

SecondaryThe Appearance of my Eye Gives me Confidence to Approach Others - Baseline

Time frame:: Baseline
Reported as:: Number · Percentage of participants

The Appearance of my Eye Gives me Confidence to Approach Others - Baseline
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	43.0	30.4	30.5
Somewhat agree (4)	25.3	31.6	26.8
Neither agree or disagree (3)	20.3	20.3	23.2
Somewhat disagree (2)	1.3	5.1	8.5
Strongly disagree (1)	2.5	3.8	7.3
No opinion	7.6	8.9	3.7

SecondaryThe Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application

Time frame:: 2 minutes after first application
Reported as:: Number · Percentage of participants

The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	46.8	39.2	37.8
Somewhat agree (4)	24.1	32.9	36.6
Neither agree or disagree (3)	20.3	11.4	15.9
Somewhat disagree (2)	1.3	3.8	2.4
Strongly disagree (1)	1.3	2.5	4.9
No opinion	6.3	10.1	2.4

SecondaryThe Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application

Time frame:: 10 hours after first application
Reported as:: Number · Percentage of participants

The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	46.8	51.9	46.3
Somewhat agree (4)	29.1	26.6	28.0
Neither agree or disagree (3)	10.1	8.9	14.6
Somewhat disagree (2)	6.3	6.3	4.9
Strongly disagree (1)	0	1.3	2.4
No opinion	6.3	5.1	3.7

SecondaryThe Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application

Time frame:: 12 hours after first application
Reported as:: Number · Percentage of participants

The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	38.0	38.0	30.5
Somewhat agree (4)	36.7	32.9	37.8
Neither agree or disagree (3)	15.2	13.9	18.3
Somewhat disagree (2)	1.3	1.3	3.7
Strongly disagree (1)	0	5.1	3.7
No opinion	7.6	7.6	6.1

SecondaryThe Appearance of my Eye Can Show How I Really Feel - Baseline

Time frame:: Baseline
Reported as:: Number · Percentage of participants

The Appearance of my Eye Can Show How I Really Feel - Baseline
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	34.2	29.1	25.6
Somewhat agree (4)	36.7	40.5	37.8
Neither agree or disagree (3)	15.2	16.5	18.3
Somewhat disagree (2)	3.8	2.5	9.8
Strongly disagree (1)	1.3	3.8	3.7
No opinion	8.9	7.6	4.9

SecondaryThe Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application

Time frame:: 2 minutes after first application
Reported as:: Number · Percentage of participants

The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	36.7	34.2	35.4
Somewhat agree (4)	34.2	43.0	40.2
Neither agree or disagree (3)	19.0	12.7	14.6
Somewhat disagree (2)	3.8	6.3	2.4
Strongly disagree (1)	1.3	0	2.4
No opinion	5.1	3.8	4.9

SecondaryThe Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application

Time frame:: 10 hours after first application
Reported as:: Number · Percentage of participants

The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	35.4	31.6	32.9
Somewhat agree (4)	31.6	36.7	31.7
Neither agree or disagree (3)	20.3	22.8	24.4
Somewhat disagree (2)	2.5	2.5	1.2
Strongly disagree (1)	0	1.3	2.4
No opinion	8.9	5.1	7.3

SecondaryThe Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application

Time frame:: 12 hours after first application
Reported as:: Number · Percentage of participants

The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	34.2	35.4	32.9
Somewhat agree (4)	38.0	36.7	40.2
Neither agree or disagree (3)	17.7	15.2	18.3
Somewhat disagree (2)	3.8	2.5	3.7
Strongly disagree (1)	0	1.3	1.2
No opinion	5.1	6.3	3.7

SecondaryMy Eye Appears Healthy - Baseline

Time frame:: Baseline
Reported as:: Number · Percentage of participants

My Eye Appears Healthy - Baseline
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	40.5	41.8	45.1
Somewhat agree (4)	35.4	31.6	25.6
Neither agree or disagree (3)	10.1	15.2	8.5
Somewhat disagree (2)	5.1	6.3	11.0
Strongly disagree (1)	6.3	3.8	7.3
No opinion	2.5	1.3	2.4

SecondaryMy Eye Appears Healthy - 2 Minutes After First Application

Time frame:: 2 minutes after first application
Reported as:: Number · Percentage of participants

My Eye Appears Healthy - 2 Minutes After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	46.8	44.3	42.7
Somewhat agree (4)	40.5	34.2	37.8
Neither agree or disagree (3)	8.9	13.9	13.4
Somewhat disagree (2)	1.3	5.1	3.7
Strongly disagree (1)	0	1.3	1.2
No opinion	2.5	1.3	1.2

SecondaryMy Eye Appears Healthy - 10 Hours After First Application

Time frame:: 10 hours after first application
Reported as:: Number · Percentage of participants

My Eye Appears Healthy - 10 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	48.1	50.6	48.8
Somewhat agree (4)	29.1	27.8	28.0
Neither agree or disagree (3)	11.4	12.7	13.4
Somewhat disagree (2)	5.1	6.3	6.1
Strongly disagree (1)	0	0	1.2
No opinion	5.1	2.5	2.4

SecondaryMy Eye Appears Healthy - 12 Hours After First Application

Time frame:: 12 hours after first application
Reported as:: Number · Percentage of participants

My Eye Appears Healthy - 12 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	54.4	51.9	47.6
Somewhat agree (4)	29.1	22.8	28.0
Neither agree or disagree (3)	11.4	11.4	18.3
Somewhat disagree (2)	1.3	5.1	2.4
Strongly disagree (1)	0	1.3	0
No opinion	2.5	5.1	2.4

SecondaryMy Eye Feels Cool - 2 Minutes After First Application

Time frame:: 2 minutes after first application
Reported as:: Number · Percentage of participants

My Eye Feels Cool - 2 Minutes After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	29.1	20.3	29.3
Somewhat agree (4)	40.5	44.3	32.9
Neither agree or disagree (3)	24.1	24.1	25.6
Somewhat disagree (2)	6.3	7.6	8.5
Strongly disagree (1)	0	2.5	2.4
No opinion	0	1.3	1.2

SecondaryMy Eye Feels Cool - 10 Hours After First Application

Time frame:: 10 hours after first application
Reported as:: Number · Percentage of participants

My Eye Feels Cool - 10 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	24.1	20.3	13.4
Somewhat agree (4)	29.1	36.7	34.1
Neither agree or disagree (3)	21.5	25.3	23.2
Somewhat disagree (2)	17.7	10.1	14.6
Strongly disagree (1)	2.5	6.3	13.4
No opinion	2.5	1.3	1.2

SecondaryMy Eye Feels Cool - 12 Hours After First Application

Time frame:: 12 hours after first application
Reported as:: Number · Percentage of participants

My Eye Feels Cool - 12 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	20.3	22.8	17.1
Somewhat agree (4)	29.1	27.8	29.3
Neither agree or disagree (3)	31.6	30.4	24.4
Somewhat disagree (2)	12.7	10.1	17.1
Strongly disagree (1)	5.1	5.1	11.0
No opinion	0	2.5	1.2

SecondaryMy Eye Appears to Sparkle - Baseline

Time frame:: Baseline
Reported as:: Number · Percentage of participants

My Eye Appears to Sparkle - Baseline
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	3.8	6.3	9.8
Somewhat agree (4)	24.1	20.3	19.5
Neither agree or disagree (3)	34.2	38.0	35.4
Somewhat disagree (2)	11.4	8.9	7.3
Strongly disagree (1)	7.6	11.4	13.4
No opinion	19.0	15.2	14.6

SecondaryMy Eye Appears to Sparkle - 2 Minutes After First Application

Time frame:: 2 minutes after first application
Reported as:: Number · Percentage of participants

My Eye Appears to Sparkle - 2 Minutes After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	6.3	8.9	14.6
Somewhat agree (4)	34.2	26.6	20.7
Neither agree or disagree (3)	30.4	35.4	37.8
Somewhat disagree (2)	5.1	6.3	4.9
Strongly disagree (1)	3.8	7.6	8.5
No opinion	20.3	15.2	13.4

SecondaryMy Eye Appears to Sparkle - 10 Hours After First Application

Time frame:: 10 hours after first application
Reported as:: Number · Percentage of participants

My Eye Appears to Sparkle - 10 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	19.0	15.2	17.1
Somewhat agree (4)	29.1	34.2	28.0
Neither agree or disagree (3)	27.8	31.6	29.3
Somewhat disagree (2)	10.1	2.5	7.3
Strongly disagree (1)	1.3	7.6	9.8
No opinion	11.4	8.9	8.5

SecondaryMy Eye Appears to Sparkle - 12 Hours After First Application

Time frame:: 12 hours after first application
Reported as:: Number · Percentage of participants

My Eye Appears to Sparkle - 12 Hours After First Application
Percentage of participants	F# PF004390 Eye Drops	F# 13418-148 Eye Drops	F#13418-158 Eye Drops
Strongly agree (5)	17.7	13.9	19.5
Somewhat agree (4)	29.1	25.3	24.4
Neither agree or disagree (3)	31.6	38.0	26.8
Somewhat disagree (2)	8.9	5.1	9.8
Strongly disagree (1)	2.5	7.6	11.0
No opinion	8.9	8.9	8.5

Adverse events

Collected over Through 24-hour end-of-study visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
F#13418-148/F#13418-158	0/41 (0%)	0/41 (0%)	0/41 (0%)
F#13418-148/F#PF004390	0/38 (0%)	0/38 (0%)	0/38 (0%)
F#13418-158/F#PF004390	0/41 (0%)	0/41 (0%)	0/41 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	F#13418-148/F#13418-158	F#13418-148/F#PF004390	F#13418-158/F#PF004390	Total
Mean	55.4 ± 15.58	59.1 ± 13.85	54.9 ± 12.47	56.4 ± 14.03

Sex: Female, Male
Sex: Female, Male(Participants)	F#13418-148/F#13418-158	F#13418-148/F#PF004390	F#13418-158/F#PF004390	Total
Female	27	22	26	75
Male	14	16	15	45

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	F#13418-148/F#13418-158	F#13418-148/F#PF004390	F#13418-158/F#PF004390	Total
White	36	36	39	111
Black or African-American	3	1	0	4
Asian	1	0	1	2
Other	1	1	1	3

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	F#13418-148/F#13418-158	F#13418-148/F#PF004390	F#13418-158/F#PF004390	Total
Hispanic or Latino	1	3	7	11
Not Hispanic or Latino	40	35	34	109

Region of Enrollment
Region of Enrollment(Participants)	F#13418-148/F#13418-158	F#13418-148/F#PF004390	F#13418-158/F#PF004390	Total
United States	41	38	41	120

Study locations

1 site

Andover Eye Associates
Andover, Massachusetts 01810, United States

References and documents

Publications

Cronau H, Kankanala RR, Mauger T. Diagnosis and management of red eye in primary care. Am Fam Physician. 2010 Jan 15;81(2):137-44. PubMed 20082509 ↗
Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30. PubMed 8961843 ↗
Murphy PJ, Lau JS, Sim MM, Woods RL. How red is a white eye? Clinical grading of normal conjunctival hyperaemia. Eye (Lond). 2007 May;21(5):633-8. doi: 10.1038/sj.eye.6702295. Epub 2006 Mar 3. PubMed 16518366 ↗

Study documents

Study protocol · Mar 28, 2017
Statistical analysis plan · Jun 19, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03198000
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Responsible party: Sponsor
First posted: Jun 23, 2017
Start date: Jun 28, 2017
Primary completion: Jul 21, 2017
Completion: Jul 21, 2017
Results posted: Aug 8, 2018
Last update: May 24, 2023

Study contacts

Gail Torkildsen, MD

principal investigator · Andover Eye Associates

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Study summary

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Keywords

In context

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Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

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Oversight

Not currently enrolling

Follow this study

Discussion

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