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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
omafilcon A
etafilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Phoenix Eye Care, PLLC
  • Lake Zurich Eye Care
  • Drs. Quinn, Foster & Assoc.
  • Vision Professionals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

omafilcon A

etafilcon A

Arm Description

Study participants are randomized to wear omafilcon A lenses.

Study participants are randomized to wear etafilcon A lenses.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
December 27, 2013
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02024698
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omafilcon A
Arm Type
Active Comparator
Arm Description
Study participants are randomized to wear omafilcon A lenses.
Arm Title
etafilcon A
Arm Type
Active Comparator
Arm Description
Study participants are randomized to wear etafilcon A lenses.
Intervention Type
Device
Intervention Name(s)
omafilcon A
Other Intervention Name(s)
Proclear 1 Day (omafilcon A)
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A
Other Intervention Name(s)
1-Day Acuvue Moist (etafilcon A)
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Comfort (Subjective Assessment)
Description
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)
Time Frame
Baseline
Title
Comfort (Subjective Assessment)
Description
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)
Time Frame
1 Week
Title
Hydration (Subjective Assessment)
Description
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)
Time Frame
Baseline
Title
Hydration (Subjective Assessment)
Description
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)
Time Frame
1 Week
Title
Vision Quality (Subjective Assessment)
Description
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)
Time Frame
Baseline
Title
Vision Satisfaction (Subjective Assessment)
Description
Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)
Time Frame
1 Week
Title
Dryness (Subjective Assessment)
Description
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)
Time Frame
1 Week
Title
Handling (Subjective Assessment)
Description
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)
Time Frame
1 Week
Title
Eye Whiteness/Redness (Subjective Assessment)
Description
Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)
Time Frame
1 Week
Title
Overall Sensation of Smoothness (Subjective Assessment)
Description
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)
Time Frame
1 Week
Title
Overall Satisfaction for Lens
Description
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)
Time Frame
1 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Siegel, OD
Organizational Affiliation
Sun City West Eye Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Eye Care, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Lake Zurich Eye Care
City
Lake Zurich
State/Province
Illinois
ZIP/Postal Code
60047
Country
United States
Facility Name
Drs. Quinn, Foster & Assoc.
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Vision Professionals
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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