This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
281
James R. Dugue, Optometrist
Mission Viejo, California, United States
Scripps Poway Eyecare & Optometry
San Diego, California, United States
Distance (4m) Monocular High Luminance High Contrast (HLHC) logMAR Visual Acuity (VA)
VA will be assessed monocularly under HLHC conditions at a test distance of 4 meters using ETDRS Charts.
Time frame: At each 1-week follow-up per wear period
Toric Lens Orientation
Toric lens orientation (scribe mark position relative to 6 o'clock) will be assessed for each eye at 15 minutes after lens insertion. Toric lens orientation will be used to define a binary endpoint, i.e. the percentage of eyes that achieve absolute toric lens rotation ≤ 10°.
Time frame: At baseline per wear period
Lens Rotational Stability with Blinks
Rotational stability will be assessed for each eye at least 15 minutes after lens insertion. Lens rotational stability with blinks will be defined as a binary endpoint, the percentage of eyes that achieve rotational stability with blinks ≤ 5°.
Time frame: At baseline per wear period
Percentage of eyes with Grade 3 or higher SLFs relating to the test lens
SLFs (Grade 3 or higher) related to study lens wear for the test lens will be assessed for each eye at all study visits (scheduled and unscheduled). SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings. The percentage of eyes with Grade 3 or higher SLF will be analyzed and will include corneal infiltrates.
Time frame: Up to 3-week follow-up
Percentage of eyes with acceptable lens fitting while wearing the test lens
Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye and used to define a binary endpoint, i.e. the percentage of eyes that achieve acceptable lens fit while wearing the test lens. Lens fit will be deemed unacceptable if any one of the following criteria are met: * limbal exposure at primary gaze or with extreme eye movement. * edge lift. * excessive movement on blink in primary gaze. * insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.
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Stam & Associates Eye Care
Jacksonville, Florida, United States
Pearson Research Center PA
Longwood, Florida, United States
Maitland Vision Centers - North Orlando Ave
Maitland, Florida, United States
Mid-State Eye
Clinton, Illinois, United States
Franklin Park Eye Center, P.C.
Franklin Park, Illinois, United States
Kannarr Eye Care - 101 North Broadway
Pittsburg, Kansas, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Advanced Eyecare - Raytown, MO
Raytown, Missouri, United States
...and 10 more locations
Time frame: Up to 3-week follow-up
Subjective Overall Comfort
Subjective overall Comfort scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) 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, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and 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: At each 1-week follow-up per wear period
Subjective Overall Quality of Vision
Subjective Overall Quality of Vision scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) 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, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and 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: At each 1-week follow-up per wear period
Subjective Overall Handling
Subjective Overall Handling scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) 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, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and 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: At each 1-week follow-up per wear period