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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
  Purpose

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


Condition Intervention
Myopia
Device: ocufilcon D
Device: ocufilcon B

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 71
Study Start Date: August 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464255

Locations
United States, California
Clinical Research Center, U.C. Berkeley, School of Optometry
Berkeley, California, United States, 94720-
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Thao N Yeh, OD U.C. Berkeley, School of Optometry
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01464255     History of Changes
Other Study ID Numbers: CV-OMC-01
Study First Received: October 26, 2011
Results First Received: April 3, 2014
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Coopervision, Inc.:
contact lenses

ClinicalTrials.gov processed this record on November 24, 2014