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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day
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
Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day
Andover Eye Associates
Andover, Massachusetts, United States
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.
Time frame: 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.
Time frame: Baseline to 60 seconds after first product application
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.
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
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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 hours after first application