A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

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

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.

Study Overview

• Status: Completed
• Conditions: Ophthalmic Solutions
• Intervention / Treatment: Drug: F# 13418-148 Eye Drops; Drug: F#13418-158 Eye Drops; Drug: F# PF-004390 Eye Drops

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
3. Male or female of any race or ethnicity, aged 18 years and older;
4. Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
5. Able to read and understand English;
6. Healthy subjects with redness in both eyes
7. History of topical ocular drugs or desire to use within the last 6 months;
8. Ocular health within normal limits,
9. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.

Exclusion Criteria:

1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
2. Known sensitivity, allergy or contraindications to any investigational product ingredient;
3. Females who are pregnant, planning to become pregnant or breastfeeding during the study;
4. Subjects who were previously screened and determined to be ineligible for the study;
5. Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
6. Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
7. Relative, partner or staff of any clinical research site personnel;
8. Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
9. Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
10. Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
11. Has a compromised immune system;
12. Has any acute or chronic, medical or psychiatric conditions
13. Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
14. Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
15. Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formula # 13418-148	Drug: F# 13418-148 Eye Drops; ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day
Experimental: Formula # 13418-158	Drug: F#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
Active Comparator: Control Formula # PF004390	Drug: F# PF-004390 Eye Drops; Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to 60 seconds after first product application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	12 hours after first application

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates

Publications and helpful links

General 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.
• Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): July 21, 2017
• Study Completion (Actual): July 21, 2017

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Eye Comfort; Eye Redness; Red Eyes
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CO-161103095739-VCCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No