Clinical trial NCT02024698: Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
Official title: Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2013-12-31
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comfort (Subjective Assessment)
timeFrame: Baseline
measure: Comfort (Subjective Assessment)
timeFrame: 1 Week
measure: Hydration (Subjective Assessment)
timeFrame: Baseline
measure: Hydration (Subjective Assessment)
timeFrame: 1 Week
measure: Vision Quality (Subjective Assessment)
timeFrame: Baseline
measure: Vision Satisfaction (Subjective Assessment)
timeFrame: 1 Week
measure: Dryness (Subjective Assessment)
timeFrame: 1 Week
measure: Handling (Subjective Assessment)
timeFrame: 1 Week
measure: Eye Whiteness/Redness (Subjective Assessment)
timeFrame: 1 Week
measure: Overall Sensation of Smoothness (Subjective Assessment)
timeFrame: 1 Week
measure: Overall Satisfaction for Lens
timeFrame: 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Eye Care, PLLC
state: Arizona
city: Lake Zurich
country: United States
facility: Lake Zurich Eye Care
state: Illinois
city: Athens
country: United States
facility: Drs. Quinn, Foster & Assoc.
state: Ohio
city: New Albany
country: United States
facility: Vision Professionals
state: Ohio
Study officials:
affiliation: Sun City West Eye Care
name: Donald Siegel, OD
role: PRINCIPAL_INVESTIGATOR
References: