A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye

Johnson & Johnson Consumer Inc. (J&JCI)1 site in 1 country120 target enrollmentJune 28, 2017

ConditionsOphthalmic Solutions

InterventionsF# 13418-148 Eye Drops F#13418-158 Eye Drops F# PF-004390 Eye Drops

DrugsF# 13418-148 Eye Drops F#13418-158 Eye Drops F# PF-004390 Eye Drops

Overview

Phase: Phase 3
Intervention: F# 13418-148 Eye Drops
Conditions: Ophthalmic Solutions
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Enrollment: 120
Locations: 1
Primary Endpoint: Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.

Detailed Description

Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.

Registry

clinicaltrials.gov

Start Date

June 28, 2017

End Date

July 21, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Responsible Party

Sponsor

Eligibility Criteria

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

•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;

Arms & Interventions

Formula # 13418-148

Intervention: F# 13418-148 Eye Drops

Formula # 13418-158

Intervention: F#13418-158 Eye Drops

Control Formula # PF004390

Intervention: F# PF-004390 Eye Drops

Outcomes

Primary Outcomes

Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application

Time Frame: Baseline to 60 seconds after first product application

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

Percentage of Participants With Response to Redness at 60 Seconds After First Product Application

Time Frame: Baseline to 60 seconds after first product application

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

Secondary Outcomes

Change From Baseline in Ocular Comfort at 10 Hours After First Product Application(Baseline to 10 hours after first product application)
Change From Baseline in Ocular Comfort at 12 Hours After First Product Application(Baseline to 12 hours after first product application)
My Eye Appears to Sparkle - 10 Hours After First Application(10 hours after first application)
Clinician Assessment of Baseline Redness(Baseline)
My Eye Feels Hydrated - 2 Minutes After First Application(2 minutes after first application)
My Eye Feels Refreshed - 2 Minutes After First Application(2 minutes after first application)
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application(2 minutes after first application)
Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application(Baseline to 60 seconds after first product application)
My Eye Feels Hydrated - Baseline(Baseline)
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application(10 hours after first application)
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application(12 hours after first application)
Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application(Baseline to 30 seconds after first product application)
Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application(Baseline to 2 minutes after first product application)
My Eye Feels Hydrated - 10 Hours After First Application(10 hours after first application)
My Eye Feels Hydrated - 12 Hours After First Application(12 hours after first application)
My Eye Feels Refreshed - 10 Hours After First Application(10 hours after first application)
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application(12 hours after first application)
My Eye Feels Cool - 12 Hours After First Application(12 hours after first application)
My Eye Feels Refreshed - 12 Hours After First Application(12 hours after first application)
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application(2 minutes after first application)
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application(10 hours after first application)
My Eye Appears Healthy - 2 Minutes After First Application(2 minutes after first application)
My Eye Feels Cool - 2 Minutes After First Application(2 minutes after first application)
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline(Baseline)
The Appearance of my Eye Can Show How I Really Feel - Baseline(Baseline)
My Eye Appears Healthy - Baseline(Baseline)
My Eye Appears Healthy - 10 Hours After First Application(10 hours after first application)
My Eye Appears Healthy - 12 Hours After First Application(12 hours after first application)
My Eye Feels Cool - 10 Hours After First Application(10 hours after first application)
My Eye Appears to Sparkle - Baseline(Baseline)
My Eye Appears to Sparkle - 12 Hours After First Application(12 hours after first application)
My Eye Appears to Sparkle - 2 Minutes After First Application(2 minutes after first application)