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

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ClinicalTrials.gov Identifier: NCT02024698
Recruitment Status : Completed
First Posted : December 31, 2013
Results First Posted : April 20, 2016
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myopia Device: omafilcon A Device: etafilcon A Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: omafilcon A
Study participants are randomized to wear omafilcon A lenses.
Device: omafilcon A
contact lens
Other Name: Proclear 1 Day (omafilcon A)

Active Comparator: etafilcon A
Study participants are randomized to wear etafilcon A lenses.
Device: etafilcon A
contact lens
Other Name: 1-Day Acuvue Moist (etafilcon A)




Primary Outcome Measures :
  1. Comfort (Subjective Assessment) [ Time Frame: Baseline ]
    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)

  2. Comfort (Subjective Assessment) [ Time Frame: 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)

  3. Hydration (Subjective Assessment) [ Time Frame: Baseline ]
    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)

  4. Hydration (Subjective Assessment) [ Time Frame: 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)

  5. Vision Quality (Subjective Assessment) [ Time Frame: 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)

  6. Vision Satisfaction (Subjective Assessment) [ Time Frame: 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)

  7. Dryness (Subjective Assessment) [ Time Frame: 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)

  8. Handling (Subjective Assessment) [ Time Frame: 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)

  9. Eye Whiteness/Redness (Subjective Assessment) [ Time Frame: 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)

  10. Overall Sensation of Smoothness (Subjective Assessment) [ Time Frame: 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)

  11. Overall Satisfaction for Lens [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024698


Locations
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United States, Arizona
Phoenix Eye Care, PLLC
Phoenix, Arizona, United States, 85032
United States, Illinois
Lake Zurich Eye Care
Lake Zurich, Illinois, United States, 60047
United States, Ohio
Drs. Quinn, Foster & Assoc.
Athens, Ohio, United States, 45701
Vision Professionals
New Albany, Ohio, United States, 43054
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Donald Siegel, OD Sun City West Eye Care
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02024698    
Other Study ID Numbers: EX-MKTG-43
First Posted: December 31, 2013    Key Record Dates
Results First Posted: April 20, 2016
Last Update Posted: July 30, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases