This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
contact lens
contact lens
Unnamed facility
Salt Lake City, Utah, United States
Unnamed facility
Virginia Beach, Virginia, United States
Unnamed facility
Laramie, Wyoming, United States
Slit Lamp Findings - Corneal Edema
Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Corneal Edema at Month 1
Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Time frame: after 1 month of lens wear
Slit Lamp Findings - Corneal Neovascularization
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Slit Lamp Findings - Corneal Neovascularization
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Time frame: after 1 month of lens wear
Slit Lamp Findings - Corneal Staining
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Slit Lamp Findings - Corneal Staining
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: after 1 month of lens wear
Slit Lamp Findings - Injection
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Slit Lamp Findings - Injection
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Time frame: after 1 month of lens wear
Slit Lamp Findings - Tarsal Abnormalities
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Slit Lamp Findings - Tarsal Abnormalities
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Time frame: after 1 month of lens wear
Slit Lamp Findings - Infiltrates
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Time frame: after 1 week of lens wear
Slit Lamp Findings - Infiltrates
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Time frame: after 1 month of lens wear
Subject Reported Symptoms
Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.
Time frame: after 1 week of lens wear
Subject Reported Symptoms
Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
Time frame: after 1 month of lens wear
Visual Acuity (VA)
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.
Time frame: after 1 week
Visual Acuity (VA)
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.
Time frame: after 1 month
Average Wear Time
Time frame: after 1 week of lens wear
Average Wear Time
Time frame: after 1 month of lens wear