The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
185
Experimental silicone hydrogel contact lens
Marketed silicone hydrogel contact lens.
Unnamed facility
Cupertino, California, United States
Unnamed facility
Huntington Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Pismo Beach, California, United States
Lens Front Surface Deposits at Day 7
Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.
Time frame: Evaluated at Day 7
Lens Front Surface Deposits at Day 14
Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.
Time frame: Evaluated at Day 14
Subject Reported Overall Lens Comfort at Day 7
The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).
Time frame: Evaluated at Day 7
Subject Reported Overall Lens Comfort at Day 14
The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).
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Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
East Lansing, Michigan, United States
Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Amarillo, Texas, United States
Time frame: Evaluated at Day 14