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

NCT02024698 | Completed Results

• 1 other identifier: EX-MKTG-43
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (11)

• Comfort (Subjective Assessment)

  Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)

  Baseline

• Comfort (Subjective Assessment)

  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)

  1 Week

• Hydration (Subjective Assessment)

  Subjective Assessment of hydration on insertion at baseline 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)

  Baseline

• Hydration (Subjective Assessment)

  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)

  1 Week

• Vision Quality (Subjective Assessment)

  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)

  Baseline

• Vision Satisfaction (Subjective Assessment)

  Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)

  1 Week

• Dryness (Subjective Assessment)

  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)

  1 Week

• Handling (Subjective Assessment)

  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)

  1 Week

• Eye Whiteness/Redness (Subjective Assessment)

  Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)

  1 Week

• Overall Sensation of Smoothness (Subjective Assessment)

  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)

  1 Week

• Overall Satisfaction for Lens

  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)

  1 Week

Study Arms (2)

omafilcon A

ACTIVE COMPARATOR

Study participants are randomized to wear omafilcon A lenses.

Device: omafilcon A

etafilcon A

ACTIVE COMPARATOR

Study participants are randomized to wear etafilcon A lenses.

Device: etafilcon A

Interventions

omafilcon A DEVICE

contact lens

Also known as: Proclear 1 Day (omafilcon A)

omafilcon A

etafilcon A DEVICE

contact lens

Also known as: 1-Day Acuvue Moist (etafilcon A)

etafilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

Phoenix Eye Care, PLLC

Phoenix, Arizona, 85032, United States

Location

Lake Zurich Eye Care

Lake Zurich, Illinois, 60047, United States

Location

Drs. Quinn, Foster & Assoc.

Athens, Ohio, 45701, United States

Location

Vision Professionals

New Albany, Ohio, 43054, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Manager Global Medical/Scientific Affairs
• Organization: CooperVision, Inc.

javega@coopervision.com

925-621-3761

Study Officials

• Donald Siegel, OD

  Sun City West Eye Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 30, 2020
• Results First Posted: April 20, 2016

Record last verified: 2020-07

Locations

US (4)