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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: ocufilcon B; Device: ocufilcon D

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-
      • Clinical Research Center, U.C. Berkeley, School of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: oculfilcon D (Daily wear soft contact lens)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Fit - Decentration After Insertion	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).	Baseline and 7 days from baseline visit
Lens Fit - Decentration at One Week	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).	7 days and 14 days from baseline visit
Lens Fit - Tightness After Insertion	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 ).	Baseline and 7 days from baseline visit
Lens Fit - Tightness at One Week	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 ).	7 days and 14 days from baseline visit
Lens Fit - Post-Blink Lens Movement After Insertion	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).	Baseline and 7 days from baseline visit
Lens Fit - Post-Blink Lens Movement Prior to Removal	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).	7 days and 14 days from baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Preference - Comfort After Insertion	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.	14 days from baseline visit
Overall Preference - Comfort Before Removal	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.	14 days from baseline visit
Overall Preference - Dryness After Insertion	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.	14 days from baseline visit
Overall Preference - Dryness Before Removal	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.	14 days from baseline visit
Overall Preference - Handling, Inserting	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.	14 days from baseline visit
Overall Preference - Handling, Removing	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.	14 days from baseline visit
Overall Lens Pair Preference	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.	14 days from baseline visit

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Thao N Yeh, OD, U.C. Berkeley, School of Optometry

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (ESTIMATE): November 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2014
• Last Update Submitted That Met QC Criteria: August 15, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-OMC-01