A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.

Not Applicable

Completed

Brief Summary: The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Detailed Description: The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.

Recruitment & Eligibility

Inclusion Criteria

Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).
Has no more than 0.75 diopters of refractive astigmatism.
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination.
Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

Exclusion Criteria

Is presently participating in any other clinical or research study including eye related clinical or research study.
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
Has any known sensitivity to fluorescein dye or products to be used in the study.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).

Arm && Interventions

Group	Intervention	Description
Control lens	Control lens	Subjects wearing the control lens for one week, either randomized as the first or second pair.
Test lens	Test lens	Subjects wearing the test lens for one week, either randomized as the first or second pair.
Test lens	Control lens	Subjects wearing the test lens for one week, either randomized as the first or second pair.
Control lens	Test lens	Subjects wearing the control lens for one week, either randomized as the first or second pair.

Primary Outcome Measures

Name	Time	Method
Primary Gaze Lag	1 week	Primary Gaze Lag (measured in mm at 0.1mm steps)
Number of Participants With Lens Centration	1 week	Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (\<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (\>0.5mm N T S I)
Post Blink Movement	1 week	Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Up Gaze Lag	1 week	Up Gaze Lag (measured in mm at 0.1mm steps)
Number of Participants With Overall Lens Fit Impression	1 week	Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Overall Fit Acceptance	1 week	Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Push-Up Tightness	1 week	Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

Secondary Outcome Measures

Name	Time	Method
Subjective Comfort Rating	1-week	Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)

Locations (2): University Eye Center at Ketchum Health
🇺🇸
Anaheim, California, United States
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
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Bloomington, Indiana, United States