Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses

Completed

Brief Summary: The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.

Detailed Description: This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.

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 an adapted soft contact lens wearer, having worn contact lenses for a minimum 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 20/20 in each eye.
Wears CLs in both eyes (monovision 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 on at least two consecutive days for each study pair.

Exclusion Criteria

Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any concomitant 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 undergone corneal refractive surgery.
Is participating in any other type of eye-related clinical or research study.

Arm && Interventions

Group	Intervention	Description
Test Lens, then Control Lens	Test Lens	Participants wore Test Lens for 2 days, and then Control Lens for 2 days
Control Lens, then Test Lens	Test Lens	Participants wore Control Lens for 2 days, and then Test Lens for 2 days
Test Lens, then Control Lens	Control Lens	Participants wore Test Lens for 2 days, and then Control Lens for 2 days
Control Lens, then Test Lens	Control Lens	Participants wore Control Lens for 2 days, and then Test Lens for 2 days

Primary Outcome Measures

Name	Time	Method
Overall Comfort With Lens	2 days	Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort.

Secondary Outcome Measures

Name	Time	Method
Overall Lens Handling	2 days	Participant response on overall handling (insertion, removal, and holding) of contact lenses assessed once after 2 days of wear, on the third day. Measured on a 0-100 integer scale, where 0=Cannot be managed, 100=Excellent handling.
Overall Vision Quality	2 days	Participant response measured once after 2 days of wear on a 0-100 integer scale, where 0= Unacceptable, 100=Excellent Vision.
Overall Lens Fit Acceptance	2 days	Measured once after 2 days of wear by investigator on lens fit alone (excludes comfort, vision, orientation) on a 0-4 scale, 0.25 steps, where 0=Can't be worn and 4=Optimum
Anterior Ocular Health - Corneal Staining Extent	2 days	Assessed once after 2 days of wear with slit lamp biomicroscopy and graded on a 0-4 integer scale, where 0=No Staining and 4=\>45% of area. Lower values represented a better outcome, e.g., a grading value of 1 would represent less corneal staining than a grade of 4. Locations (central, nasal, temporal, superior, inferior) were graded separately.