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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: etafilcon A; Device: omafilcon A

• Registration Number: NCT02024698
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Study Start: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Results First Submitted: 2016-02-24
• Results First Submitted QC: 2016-04-18
• Results First Posted: 2016-04-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-19
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
etafilcon A	etafilcon A	Study participants are randomized to wear etafilcon A lenses.
omafilcon A	omafilcon A	Study participants are randomized to wear omafilcon A lenses.

Primary Outcome Measures

Name	Time	Method
Handling (Subjective Assessment)	1 Week	Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)
Overall Sensation of Smoothness (Subjective Assessment)	1 Week	Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)
Comfort (Subjective Assessment)	1 Week	Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Hydration (Subjective Assessment)	1 Week	Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Vision Satisfaction (Subjective Assessment)	1 Week	Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)
Dryness (Subjective Assessment)	1 Week	Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)
Vision Quality (Subjective Assessment)	Baseline	Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)
Eye Whiteness/Redness (Subjective Assessment)	1 Week	Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)
Overall Satisfaction for Lens	1 Week	Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)

Trial Locations

Locations (4)

Phoenix Eye Care, PLLC; 🇺🇸 Phoenix, Arizona, United States

Lake Zurich Eye Care; 🇺🇸 Lake Zurich, Illinois, United States

Vision Professionals; 🇺🇸 New Albany, Ohio, United States

Drs. Quinn, Foster & Assoc.; 🇺🇸 Athens, Ohio, United States