Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing study of Johnson \& Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI investigational contact lenses on a daily wear basis.
Objective of the study is to demonstrate the safety and efficacy of the JJVCI investigational contact lens by comparison to the marketed, monthly replacement contact lens, both worn for thirty days on a daily wear modality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
224
Investigational contact lens
Marketed Monthly Replacement Lens (Control)
Vue Optical Boutique
Jacksonville, Florida, United States
Omega Vision Center, PA / Sabal Eye Care
Longwood, Florida, United States
Eyecare Associates
Bloomington, Illinois, United States
Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.
Time frame: Up to 3 Month Follow-up
Visual Acuity
Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.
Time frame: Up to 3 month Follow-up
Symptoms
Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item "Experienced Eye Symptoms or Problems?" were reported.
Time frame: Up to 3 month Follow-up
Average Wear Time
Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.
Time frame: 3 month Follow-up
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Advantage Eyecare Associates, LLC
Broadway Pittsburg, Kansas, United States
Dr. Debbie H. Kim, OD
Closter, New Jersey, United States
Sacco Eye Group
Vestal, New York, United States
Pickens Family Eye Care
Pickens, South Carolina, United States
Premier Vision
Amarillo, Texas, United States
William J. Bogus OD
Salt Lake City, Utah, United States
Timothy R. Poling, OD
Salem, Virginia, United States