Clinical Evaluation of Daily Disposable Contact Lenses

Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one
or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses.
The first randomly assigned lens type was worn for 3 days, with daily replacement, followed
by 3 days of wear of the other lens type, with daily replacement.

Inclusion Criteria:

- Is between 18 and 40 years of age (inclusive)

- Has had a self-reported visual exam in the last two years

- Is an adapted soft CL wearer

- Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming
there are no contraindications for doing so

- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)

- Has less than 1.25 D spectacle cylinder in each eye.

- Baseline vision of 20/40 or better (in each eye) with their habitual vision
correction or 20/20 best-corrected.

- Is correctable to at least 20/25 distance visual acuity with study contact lenses in
each eye

- Has clear corneas and no active ocular disease

- Has read, understood and signed the information consent letter

- Is willing to comply with the wear schedule (at least 3 full days)

- Is willing to comply with the visit schedule

Exclusion Criteria:

- Has never worn contact lenses before.

- Currently wears rigid gas permeable contact lenses.

- Has a history of not achieving comfortable CL wear (3 days per week; > 8 hours/day)

- Has a CL prescription outside the range of - 1.00 to -6.00D

- Has a spectacle cylinder greater than -1.25D of cylinder in either eye.

- Has best corrected spectacle distance vision worse then 20/25 in either eye.

- Has any systemic disease affecting ocular health.

- Is using any systemic or topical medications, (includes rewetting drops, artificial
tears and allergy drops), that will affect ocular health. Occasional use is
acceptable but not during the trial.

- Has any ocular pathology or severe insufficiency of lacrimal secretion

- Has persistent, clinically significant corneal or conjunctival staining

- Has active neovascularization or any central corneal scars.

- Is aphakic.

- Is presbyopic.

- Has undergone corneal refractive surgery.

- Is participating in any other type of eye related clinical or research study.