Ophthalmic SolutionsPhase 3NCT03198000
A Study to Evaluate the Efficacy of Investigational OTC Eye Drops
A Phase 3 study testing F# 13418-148 Eye Drops, F#13418-158 Eye Drops and F# PF-004390 Eye Drops in people with Ophthalmic Solutions, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmic Solutions
- What is being tested?
- F# 13418-148 Eye Drops, F#13418-158 Eye Drops and F# PF-004390 Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 21 Jul 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: 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.
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
- Ophthalmic Solutions
- Being tested
- F# 13418-148 Eye Drops, F#13418-158 Eye Drops, F# PF-004390 Eye Drops
- Keywords
- Eye Redness, Eye Comfort, Red Eyes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F# 13418-148 Eye DropsDrug
ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day
F#13418-158 Eye DropsDrug
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
F# PF-004390 Eye DropsDrug
Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day
| Study group | Role | What they receive |
|---|---|---|
| Formula # 13418-148 | Experimental | Not described Receives: Drug: F# 13418-148 Eye Drops |
| Formula # 13418-158 | Experimental | Not described Receives: Drug: F#13418-158 Eye Drops |
| Control Formula # PF004390 | Active comparator | Not described Receives: Drug: F# PF-004390 Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 60 seconds after first product application
Secondary outcomes (32)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 hours after first application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start28 Jun 2017
- Primary completion21 Jul 2017
- Study completion21 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ophthalmic SolutionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198000
- Sponsor's protocol ID
- CO-161103095739-VCCT
- Status last verified
- Apr 2023
- First submitted
- 22 Jun 2017
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 20082509Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30.
PubMed 8961843Murphy 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 at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye
- ClinicalTrials.gov ID
- NCT03198000
- Acronym / sponsor ID
- CO-161103095739-VCCT
- Conditions
- Ophthalmic Solutions
- Keywords
- Eye Redness, Eye Comfort, Red Eyes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formula # 13418-148 | Experimental | Drug: F# 13418-148 Eye Drops |
| Formula # 13418-158 | Experimental | Drug: F#13418-158 Eye Drops |
| Control Formula # PF004390 | Active comparator | Drug: F# PF-004390 Eye Drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F# 13418-148 Eye Dropsocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day | Drug | Formula # 13418-148 |
| F#13418-158 Eye Dropsocular 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 | Drug | Formula # 13418-158 |
| F# PF-004390 Eye DropsOcular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day | Drug | Control Formula # PF004390 |
Primary outcome
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.
32 secondary outcomes
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
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
Clinician Assessment of Baseline Redness
Time frame: Baseline
Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application
Time frame: Baseline to 60 seconds after first product application
Change From Baseline in Ocular Comfort at 10 Hours After First Product Application
Time frame: Baseline to 10 hours after first product application
Change From Baseline in Ocular Comfort at 12 Hours After First Product Application
Time frame: Baseline to 12 hours after first product application
My Eye Feels Hydrated - Baseline
Time frame: Baseline
My Eye Feels Hydrated - 2 Minutes After First Application
Time frame: 2 minutes after first application
My Eye Feels Hydrated - 10 Hours After First Application
Time frame: 10 hours after first application
My Eye Feels Hydrated - 12 Hours After First Application
Time frame: 12 hours after first application
My Eye Feels Refreshed - 2 Minutes After First Application
Time frame: 2 minutes after first application
My Eye Feels Refreshed - 10 Hours After First Application
Time frame: 10 hours after first application
My Eye Feels Refreshed - 12 Hours After First Application
Time frame: 12 hours after first application
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline
Time frame: Baseline
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application
Time frame: 2 minutes after first application
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application
Time frame: 10 hours after first application
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application
Time frame: 12 hours after first application
The Appearance of my Eye Can Show How I Really Feel - Baseline
Time frame: Baseline
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application
Time frame: 2 minutes after first application
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application
Time frame: 10 hours after first application
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application
Time frame: 12 hours after first application
My Eye Appears Healthy - Baseline
Time frame: Baseline
My Eye Appears Healthy - 2 Minutes After First Application
Time frame: 2 minutes after first application
My Eye Appears Healthy - 10 Hours After First Application
Time frame: 10 hours after first application
My Eye Appears Healthy - 12 Hours After First Application
Time frame: 12 hours after first application
My Eye Feels Cool - 2 Minutes After First Application
Time frame: 2 minutes after first application
My Eye Feels Cool - 10 Hours After First Application
Time frame: 10 hours after first application
My Eye Feels Cool - 12 Hours After First Application
Time frame: 12 hours after first application
My Eye Appears to Sparkle - Baseline
Time frame: Baseline
My Eye Appears to Sparkle - 2 Minutes After First Application
Time frame: 2 minutes after first application
My Eye Appears to Sparkle - 10 Hours After First Application
Time frame: 10 hours after first application
My Eye Appears to Sparkle - 12 Hours After First Application
Time frame: 12 hours after first application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20082509Cronau H, Kankanala RR, Mauger T. Diagnosis and management of red eye in primary care. Am Fam Physician. 2010 Jan 15;81(2):137-44.
- Background: PubMed 8961843Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30.
- Background: PubMed 16518366Murphy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Torkildsen, MD principal investigator
Andover Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing F# 13418-148 Eye Drops, F#13418-158 Eye Drops and F# PF-004390 Eye Drops in people with Ophthalmic Solutions, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198000, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.