To evaluate and compare the performance of a new contact lens to a marketed contact lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
A daily disposable contact lens
A marketed daily disposable contact lens
Unnamed facility
Bloomfield, Connecticut, United States
Unnamed facility
Tallahassee, Florida, United States
Unnamed facility
Overland Park, Kansas, United States
Unnamed facility
Jamestown, New York, United States
Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range from 0-120.
Time frame: After 7 to 9 days of lens wear
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0-120.
Time frame: After 7 to 9 days of lens wear
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0-120.
Time frame: After 7 to 9 days of lens wear
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Unnamed facility
Kingston, Pennsylvania, United States
Unnamed facility
Moon Township, Pennsylvania, United States