Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses

Not Applicable

Completed

Brief Summary: The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A when worn on a daily disposable modality over a period of approximately one week each.

Detailed Description: The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates somofilcon A (test lens) and verofilcon A (control lens).

Recruitment & Eligibility

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
Has an astigmatism of ≤ 1.00 D in subjective refraction;
Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
Demonstrates an acceptable fit with the study lenses;
Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria

A person may be excluded from the study if he/she:

Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
Is aphakic;
Has undergone refractive error surgery;
Is an employee of the Centre for Ocular Research & Education;
Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or MIKI (EX-MKTG-114) Study;
Has participated in any clinical trials within a week prior to the study.

Arm && Interventions

Group	Intervention	Description
somofilcon A	somofilcon A	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week.
verofilcon A	verofilcon A	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.

Primary Outcome Measures

Name	Time	Method
Subjective Ratings for Lens Handling for Lens Insertion	1 week	Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).
Subjective Ratings for Lens Handling for Lens Removal	1 week	Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy).

Secondary Outcome Measures

Name	Time	Method
Lens Fit - Lens Push-up Tightness	1-week	The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Lens Fit - Centration	1-week	Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive \& occasionally encroaching limbus)
Lens Fit - Post-blink Movement	1-week	Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps