A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ophthalmic Solutions

Intervention / Treatment
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* Drug: F# 13418-148 Eye Drops
* Drug: F#13418-158 Eye Drops
* Drug: F# PF-004390 Eye Drops


Participation Criteria
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Eligibility Criteria
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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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye Redness, Eye Comfort, Red Eyes