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NCT03198000

A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

Completed Phase 3 Results posted Last updated 24 May 2023
What this trial tests

Phase 3 trial testing F# 13418-148 Eye Drops in Ophthalmic Solutions in 120 participants. Completed in 21 July 2017.

Timeline
28 June 2017
Primary endpoint
21 July 2017
21 July 2017

Quick facts

Lead sponsorJohnson & Johnson Consumer Inc. (J&JCI)
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment120
Start date28 June 2017
Primary completion21 July 2017
Estimated completion21 July 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI) — full company profile →

Who can join

18 and older, any sex, with Ophthalmic Solutions. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application Primary · Baseline to 60 seconds after first product application

Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.

GroupValue95% CI
F# PF004390 Eye Drops0.31± 0.050
F# 13418-148 Eye Drops0.27± 0.050
F#13418-158 Eye Drops0.32± 0.049
Percentage of Participants With Response to Redness at 60 Seconds After First Product Application Primary · Baseline to 60 seconds after first product application

The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.

GroupValue95% CI
F# PF004390 Eye Drops53.6
F# 13418-148 Eye Drops50.1
F#13418-158 Eye Drops50.1
Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application Secondary · Baseline to 30 seconds after first product application

Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.

GroupValue95% CI
F# PF004390 Eye Drops0.10± 0.046
F# 13418-148 Eye Drops0.09± 0.046
F#13418-158 Eye Drops0.11± 0.046
Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application Secondary · Baseline to 2 minutes after first product application

Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.

GroupValue95% CI
F# PF004390 Eye Drops0.88± 0.048
F# 13418-148 Eye Drops0.80± 0.048
F#13418-158 Eye Drops0.83± 0.048
Clinician Assessment of Baseline Redness Secondary · 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.

GroupValue95% CI
F# PF004390 Eye Drops1.64± 0.537
F# 13418-148 Eye Drops1.66± 0.497
F#13418-158 Eye Drops1.76± 0.498
Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application Secondary · Baseline to 60 seconds after first product application

Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.

GroupValue95% CI
F# PF004390 Eye Drops-1.4± 0.21
F# 13418-148 Eye Drops-1.1± 0.21
F#13418-158 Eye Drops-1.2± 0.20
Change From Baseline in Ocular Comfort at 10 Hours After First Product Application Secondary · Baseline to 10 hours after first product application

Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.

GroupValue95% CI
F# PF004390 Eye Drops-1.4± 0.20
F# 13418-148 Eye Drops-1.7± 0.20
F#13418-158 Eye Drops-1.6± 0.20
Change From Baseline in Ocular Comfort at 12 Hours After First Product Application Secondary · Baseline to 12 hours after first product application

Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.

GroupValue95% CI
F# PF004390 Eye Drops-1.4± 0.20
F# 13418-148 Eye Drops-1.5± 0.20
F#13418-158 Eye Drops-1.6± 0.20
My Eye Feels Hydrated - Baseline Secondary · 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.

Strongly agree (5)
GroupValue95% CI
F# PF004390 Eye Drops8.9
F# 13418-148 Eye Drops10.1
F#13418-158 Eye Drops8.5
Somewhat agree (4)
GroupValue95% CI
F# PF004390 Eye Drops30.4
F# 13418-148 Eye Drops34.2
F#13418-158 Eye Drops28.0
Neither agree or disagree (3)
GroupValue95% CI
F# PF004390 Eye Drops10.1
F# 13418-148 Eye Drops12.7
F#13418-158 Eye Drops9.8
Somewhat disagree (2)
GroupValue95% CI
F# PF004390 Eye Drops30.4
F# 13418-148 Eye Drops30.4
F#13418-158 Eye Drops34.1
Strongly disagree (1)
GroupValue95% CI
F# PF004390 Eye Drops17.7
F# 13418-148 Eye Drops10.1
F#13418-158 Eye Drops19.5
No opinion
GroupValue95% CI
F# PF004390 Eye Drops2.5
F# 13418-148 Eye Drops2.5
F#13418-158 Eye Drops0
My Eye Feels Hydrated - 2 Minutes After First Application Secondary · 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.

Strongly agree (5)
GroupValue95% CI
F# PF004390 Eye Drops45.6
F# 13418-148 Eye Drops39.2
F#13418-158 Eye Drops43.9
Somewhat agree (4)
GroupValue95% CI
F# PF004390 Eye Drops48.1
F# 13418-148 Eye Drops49.4
F#13418-158 Eye Drops42.7
Neither agree or disagree (3)
GroupValue95% CI
F# PF004390 Eye Drops3.8
F# 13418-148 Eye Drops3.8
F#13418-158 Eye Drops7.3
Somewhat disagree (2)
GroupValue95% CI
F# PF004390 Eye Drops1.3
F# 13418-148 Eye Drops6.3
F#13418-158 Eye Drops6.1
Strongly disagree (1)
GroupValue95% CI
F# PF004390 Eye Drops1.3
F# 13418-148 Eye Drops1.3
F#13418-158 Eye Drops0
No opinion
GroupValue95% CI
F# PF004390 Eye Drops0
F# 13418-148 Eye Drops0
F#13418-158 Eye Drops0
My Eye Feels Hydrated - 10 Hours After First Application Secondary · 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.

Strongly agree (5)
GroupValue95% CI
F# PF004390 Eye Drops31.6
F# 13418-148 Eye Drops43.0
F#13418-158 Eye Drops29.3
Somewhat agree (4)
GroupValue95% CI
F# PF004390 Eye Drops41.8
F# 13418-148 Eye Drops35.4
F#13418-158 Eye Drops41.5
Neither agree or disagree (3)
GroupValue95% CI
F# PF004390 Eye Drops10.1
F# 13418-148 Eye Drops8.9
F#13418-158 Eye Drops11.0
Somewhat disagree (2)
GroupValue95% CI
F# PF004390 Eye Drops11.4
F# 13418-148 Eye Drops8.9
F#13418-158 Eye Drops13.4
Strongly disagree (1)
GroupValue95% CI
F# PF004390 Eye Drops2.5
F# 13418-148 Eye Drops2.5
F#13418-158 Eye Drops4.9
No opinion
GroupValue95% CI
F# PF004390 Eye Drops1.3
F# 13418-148 Eye Drops1.3
F#13418-158 Eye Drops0
My Eye Feels Hydrated - 12 Hours After First Application Secondary · 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.

Strongly agree (5)
GroupValue95% CI
F# PF004390 Eye Drops36.7
F# 13418-148 Eye Drops35.4
F#13418-158 Eye Drops30.5
Somewhat agree (4)
GroupValue95% CI
F# PF004390 Eye Drops43.0
F# 13418-148 Eye Drops40.5
F#13418-158 Eye Drops41.5
Neither agree or disagree (3)
GroupValue95% CI
F# PF004390 Eye Drops3.8
F# 13418-148 Eye Drops6.3
F#13418-158 Eye Drops7.3
Somewhat disagree (2)
GroupValue95% CI
F# PF004390 Eye Drops12.7
F# 13418-148 Eye Drops8.9
F#13418-158 Eye Drops17.1
Strongly disagree (1)
GroupValue95% CI
F# PF004390 Eye Drops2.5
F# 13418-148 Eye Drops6.3
F#13418-158 Eye Drops3.7
No opinion
GroupValue95% CI
F# PF004390 Eye Drops0
F# 13418-148 Eye Drops0
F#13418-158 Eye Drops0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing