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A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03198000
Recruitment Status : Completed
First Posted : June 23, 2017
Results First Posted : August 8, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

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.

Condition or disease Intervention/treatment Phase
Ophthalmic Solutions Drug: F# 13418-148 Eye Drops Drug: F#13418-158 Eye Drops Drug: F# PF-004390 Eye Drops Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : July 21, 2017

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




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application [ Time Frame: 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.

  2. Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application [ Time Frame: 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.

  3. Clinician Assessment of Baseline Redness [ Time Frame: 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.

  4. Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application [ Time Frame: 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.

  5. Change From Baseline in Ocular Comfort at 10 Hours After First Product Application [ Time Frame: 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.

  6. Change From Baseline in Ocular Comfort at 12 Hours After First Product Application [ Time Frame: 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.

  7. My Eye Feels Hydrated - Baseline [ Time Frame: 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.

  8. My Eye Feels Hydrated - 2 Minutes After First Application [ Time Frame: 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.

  9. My Eye Feels Hydrated - 10 Hours After First Application [ Time Frame: 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. My Eye Feels Hydrated - 12 Hours After First Application [ Time Frame: 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.

  11. My Eye Feels Refreshed - 2 Minutes After First Application [ Time Frame: 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.

  12. My Eye Feels Refreshed - 10 Hours After First Application [ Time Frame: 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.

  13. My Eye Feels Refreshed - 12 Hours After First Application [ Time Frame: 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.

  14. The Appearance of my Eye Gives me Confidence to Approach Others - Baseline [ Time Frame: 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.

  15. The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application [ Time Frame: 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.

  16. The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application [ Time Frame: 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.

  17. The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application [ Time Frame: 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.

  18. The Appearance of my Eye Can Show How I Really Feel - Baseline [ Time Frame: 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.

  19. The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application [ Time Frame: 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.

  20. The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application [ Time Frame: 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.

  21. The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application [ Time Frame: 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.

  22. My Eye Appears Healthy - Baseline [ Time Frame: 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.

  23. My Eye Appears Healthy - 2 Minutes After First Application [ Time Frame: 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.

  24. My Eye Appears Healthy - 10 Hours After First Application [ Time Frame: 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.

  25. My Eye Appears Healthy - 12 Hours After First Application [ Time Frame: 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.

  26. My Eye Feels Cool - 2 Minutes After First Application [ Time Frame: 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.

  27. My Eye Feels Cool - 10 Hours After First Application [ Time Frame: 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.

  28. My Eye Feels Cool - 12 Hours After First Application [ Time Frame: 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.

  29. My Eye Appears to Sparkle - Baseline [ Time Frame: 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.

  30. My Eye Appears to Sparkle - 2 Minutes After First Application [ Time Frame: 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.

  31. My Eye Appears to Sparkle - 10 Hours After First Application [ Time Frame: 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.

  32. My Eye Appears to Sparkle - 12 Hours After First Application [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198000


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
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Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):
Statistical Analysis Plan  [PDF] June 19, 2017
Study Protocol  [PDF] March 28, 2017


Publications:
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Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT03198000    
Other Study ID Numbers: CO-161103095739-VCCT
First Posted: June 23, 2017    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: September 18, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):
Eye Redness
Eye Comfort
Red Eyes
Additional relevant MeSH terms:
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Ophthalmic Solutions
Pharmaceutical Solutions