Comparative Study of Two Marketed 1-day Soft Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01464255
First received: October 26, 2011
Last updated: August 15, 2014
Last verified: August 2014

October 26, 2011
August 15, 2014
August 2011
October 2011   (final data collection date for primary outcome measure)
  • Lens Fit - Decentration After Insertion [ Time Frame: Baseline and 7 days from baseline visit ] [ Designated as safety issue: No ]
    The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).
  • Lens Fit - Decentration at One Week [ Time Frame: 7 days and 14 days from baseline visit ] [ Designated as safety issue: No ]
    The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).
  • Lens Fit - Tightness After Insertion [ Time Frame: Baseline and 7 days from baseline visit ] [ Designated as safety issue: No ]
    The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).
  • Lens Fit - Tightness at One Week [ Time Frame: 7 days and 14 days from baseline visit ] [ Designated as safety issue: No ]
    The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).
  • Lens Fit - Post-Blink Lens Movement After Insertion [ Time Frame: Baseline and 7 days from baseline visit ] [ Designated as safety issue: No ]
    The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).
  • Lens Fit - Post-Blink Lens Movement Prior to Removal [ Time Frame: 7 days and 14 days from baseline visit ] [ Designated as safety issue: No ]
    The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).
Objective Lens Fit Measures [ Time Frame: 1 week ] [ Designated as safety issue: No ]
This outcome is an investigator assessment of the lens position and lens movement while lens is on eye.
Complete list of historical versions of study NCT01464255 on ClinicalTrials.gov Archive Site
  • Overall Preference - Comfort After Insertion [ Time Frame: 14 days from baseline visit ] [ Designated as safety issue: No ]
    Participant's subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
  • Overall Preference - Comfort Before Removal [ Time Frame: 14 days from baseline visit ] [ Designated as safety issue: No ]
    Participant's subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
  • Overall Preference - Dryness After Insertion [ Time Frame: 14 days from baseline visit ] [ Designated as safety issue: No ]
    Participant's subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
  • Overall Preference - Dryness Before Removal [ Time Frame: 14 days from baseline visit ] [ Designated as safety issue: No ]
    Participant's subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
  • Overall Preference - Handling, Inserting [ Time Frame: 14 days from baseline visit ] [ Designated as safety issue: No ]
    Participant's subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
  • Overall Preference - Handling, Removing [ Time Frame: 14 days from baseline visit ] [ Designated as safety issue: No ]
    Participant's subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
  • Overall Lens Pair Preference [ Time Frame: 14 days from baseline visit ] [ Designated as safety issue: No ]
    Participant's subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
Subjective Subject Assessments of comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Subjective measures of comfort - subject will complete a questionnaire with measures rated on a 0 to 100 point scale This outcome is a score calculated from individual comfort-related questions asked on a 0 -100 scale: 0 = most negative response to 100 = most positive response.
Not Provided
Not Provided
 
Comparative Study of Two Marketed 1-day Soft Contact Lenses
Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B

This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.

This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Myopia
  • Device: ocufilcon D
    Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
    Other Name: oculfilcon D (Daily wear soft contact lens)
  • Device: ocufilcon B
    Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
    Other Name: oculfilcon B (Daily wear soft contact lens)
  • Experimental: ocufilcon D
    Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
    Intervention: Device: ocufilcon B
  • Active Comparator: ocufilcon B
    Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
    Intervention: Device: ocufilcon D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
November 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has had a self reported oculo-visual examination in the last two years.
  • Is able to wear the study lenses for at least eight hours a day, seven days a week
  • Aged 18-40 years and has full legal capacity as a volunteer
  • Has a distance contact lens prescription from -0.25 and -6.00D inclusive
  • Has spectacle astigmatism of < 1.00D in each eye
  • Baseline vision of 20/20 best-corrected in each eye.
  • Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
  • Has read and understood the consent form and willing to sign consent form
  • Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).

Exclusion Criteria:

  • Currently wears contact lenses on an extended wear basis.
  • Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
  • Has undergone anterior ocular surgery
  • Is aphakic
  • Has never worn contact lenses before
  • Has any systemic disease which clinically contraindicates contact lenses
  • Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)
  • Use of systemic or topical medications that will affect ocular health or visual performance
  • Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3
  • Not possible to achieve a satisfactory fit with the lens design used in the study
  • Has keratoconus or other corneal irregularity
  • Participating in another eye-related clinical trial
  • Pregnant, lactating or planning a pregnancy
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464255
CV-OMC-01
No
Coopervision, Inc.
Coopervision, Inc.
Not Provided
Principal Investigator: Thao N Yeh, OD U.C. Berkeley, School of Optometry
Coopervision, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP