A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

Not Applicable

Completed

Brief Summary: The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).

Detailed Description: The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Recruitment & Eligibility

Inclusion Criteria

Is at least 18 years of age and has full legal capacity to volunteer.
Is no greater than 55 years of age.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
Has spectacle cylinder ≤1.00D in both eyes.
Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
Wears CLs in both eyes (monvision acceptable, but not monofit)
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination.
Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Exclusion Criteria

Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
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 strabismus/amblyopia.
Has undergone corneal refractive surgery.
Is pregnant, lactating or planning a pregnancy.
Is participating in any concurrent clinical or research study.

Arm && Interventions

Group	Intervention	Description
Test Contact Lens	Nelfilcon A	Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.
nelfilcon A lens (control)	Nelfilcon A	Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.
Test Contact Lens	Test Contact Lens	Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.
nelfilcon A lens (control)	Test Contact Lens	Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.

Primary Outcome Measures

Name	Time	Method
Lens Fit Acceptance	1-Week	Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Secondary Outcome Measures

Name	Time	Method

Locations (1): Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
🇺🇸
Bloomington, Indiana, United States