This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of \~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
171
One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
Medical Research Foundation, Sankara Nethralaya
Chennai, India
Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)
The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.
Time frame: Up to 6 months
Overall Comfort Score
Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM 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 +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.
Time frame: Time Frame Up to 6 months
Overall Vision Score
Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM 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 +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.
Time frame: Time Frame Up to 6 months
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One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.
2-week contact lens adaptation period wearing prior to randomization