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OpenTrials
Completed

NCT Number: NCT01464255

Comparative Study of Two Marketed 1-day Soft Contact Lenses

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center, U.C. Berkeley, School of Optometry

Berkeley, California, 94720-, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ocufilcon D

Device

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 names: oculfilcon D (Daily wear soft contact lens)

Ocufilcon B

Device

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 names: oculfilcon B (Daily wear soft contact lens)

Primary outcomes

  1. Lens Fit - Decentration After Insertion

    Time frame: Baseline and 7 days from baseline visit

    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).

  2. Lens Fit - Decentration at One Week

    Time frame: 7 days and 14 days from baseline visit

    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).

  3. Lens Fit - Tightness After Insertion

    Time frame: Baseline and 7 days from baseline visit

    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 ).

  4. Lens Fit - Tightness at One Week

    Time frame: 7 days and 14 days from baseline visit

    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 ).

  5. Lens Fit - Post-Blink Lens Movement After Insertion

    Time frame: Baseline and 7 days from baseline visit

    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).

  6. Lens Fit - Post-Blink Lens Movement Prior to Removal

    Time frame: 7 days and 14 days from baseline visit

    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 outcomes

  1. Overall Preference - Comfort After Insertion

    Time frame: 14 days from baseline visit

    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.

  2. Overall Preference - Comfort Before Removal

    Time frame: 14 days from baseline visit

    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.

  3. Overall Preference - Dryness After Insertion

    Time frame: 14 days from baseline visit

    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.

  4. Overall Preference - Dryness Before Removal

    Time frame: 14 days from baseline visit

    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.

  5. Overall Preference - Handling, Inserting

    Time frame: 14 days from baseline visit

    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.

  6. Overall Preference - Handling, Removing

    Time frame: 14 days from baseline visit

    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.

  7. Overall Lens Pair Preference

    Time frame: 14 days from baseline visit

    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.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2011
Registry last updated
Aug 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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