Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: omafilcon A; Device: etafilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02024698

EX-MKTG-43

Details and patient eligibility

About

The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.

Full description

The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.

Enrollment: 43 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Is between 18 and 40 years of age (inclusive)
• Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
• Has had a self-reported visual exam in the last two years
• Is an adapted soft CL (Contact Lens) wearer
• Must be able to wear their lenses at least 6 full days over the 7 days; 14 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 0.75D (Diopters) spectacle cylinder in each eye.
• Is correctable to a visual acuity of 20/25 or better in both eyes
• 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 40 hrs per week)
• Is willing to comply with the visit schedule

Exclusion criteria

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

• Has never worn contact lenses before.
• Currently wears rigid gas permeable contact lenses.
• Has a history of not achieving comfortable CL wear (5 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 -0.50D 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 that will affect ocular health.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

43 participants in 2 patient groups

omafilcon A

Active Comparator group

Description:

Study participants are randomized to wear omafilcon A lenses.

Treatment:

Device: omafilcon A

etafilcon A

Active Comparator group

Description:

Study participants are randomized to wear etafilcon A lenses.

Treatment:

Device: etafilcon A