Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: fanfilcon A test lens; Device: ocufilcon D control lens; Device: etafilcon A control lens

Detailed Description

This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Whittier, California, United States, 90606
      • Golden Optometric Group
  • Florida
    • Longwood, Florida, United States, 32779
      • Omega Vision Center PA (DBA Sabal Eye Care)
    • Sarasota, Florida, United States, 34232
      • Golden Vision
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Texas
    • Tyler, Texas, United States, 75703
      • Frazier Vision, Inc
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Office of William J. Bogus, O.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be a currently adapted soft contact lens wearer (>1 month of lens wear).
• Be at least 18 years of age.
• Refractive astigmatism <1.00D in both eyes.
• Have clear corneas and be free of any anterior segment disorders.
• Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
• Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
• Require visual correction in both eyes (monovision allowed, no monofit).

• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  1. No amblyopia
  2. No strabismus
  3. No evidence of lid abnormality or infection
  4. No conjunctival abnormality or infection that would contraindicate contact lens wear
  5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
  6. No other active ocular disease.
• Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
• Willing to comply with the wear and study visit schedule.

Exclusion Criteria:

• Using CooperVision Avaira Vitality, J&J Acuvue 2 or CooperVision Biomedics 55.
• Require toric or multifocal contact lenses.
• Previously shown a sensitivity to any of the study solution components.
• Any systemic or ocular disease or allergies affecting ocular health.
• Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
• Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
• Keratoconus or other corneal irregularity.
• Aphakia or amblyopia.
• Have undergone corneal refractive surgery or any anterior segment surgery.
• Abnormal lacrimal secretions.
• Has diabetes.
• Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• History of chronic eye disease (e.g. glaucoma).
• Pregnant or lactating or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial or in last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ocufilcon D control lens, then fanfilcon A test lens; Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.	Device: fanfilcon A test lens; Silicone hydrogel contact lens; Other Names: test lens; Avaira Vitality; Device: ocufilcon D control lens; hydrogel contact lens; Other Names: Biomedics 55 Premier; ocufilcon D (4-weekly) control lens
Experimental: etafilcon A controls, then fanfilcon A test lens; Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.	Device: fanfilcon A test lens; Silicone hydrogel contact lens; Other Names: test lens; Avaira Vitality; Device: etafilcon A control lens; hydrogel contact lens; Other Names: etafilcon A (2-weekly) control lens; Acuvue 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Overall Comfort Rating	Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses	Two weeks
Subjective Overall Comfort Rating	Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses	Four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Wearing Time	Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes	Two weeks
Average Wearing Time	Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes	Four weeks
Average Comfortable Wearing Time	Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.	Two weeks
Average Comfortable Wearing Time	Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.	Four weeks
Lens Centration	Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).	Baseline (after 15 minutes)
Lens Centration	Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).	Two weeks
Lens Centration	Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).	Four weeks
Corneal Coverage	Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)	Baseline (after 15 minutes of lens dispense)
Corneal Coverage	Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)	Two weeks
Corneal Coverage	Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)	Four weeks
Post-Blink Movement	Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Baseline (after 15 minutes of lens dispense)
Post-Blink Movement	Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Two weeks
Post-Blink Movement	Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Four weeks
Lens Tightness - Push-up Test	Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)	Baseline (after 15 minutes of lens dispense)
Lens Tightness - Push-up Test	Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)	Two weeks
Lens Tightness - Push-up Test	Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)	Four weeks
Overall Lens Fit Acceptance	Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)	Baseline (after 15 minutes of lens dispense)
Overall Lens Fit Acceptance	Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)	Two weeks
Overall Lens Fit Acceptance	Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)	Four weeks
Rating of Lens Surface Wettability	Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).	Baseline (after 15 minutes of lens dispense)
Rating of Lens Surface Wettability	Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).	Two weeks
Rating of Lens Surface Wettability	Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).	Four weeks
Presence of Film Deposits	Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).	Two weeks
Presence of Film Deposits	Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).	Four weeks
Number of White Spot Deposits	Number of white spot deposits assessed using slit lamp with white light, low medium magnification	Two weeks
Number of White Spot Deposits	Number of white spot deposits assessed using slit lamp with white light, low medium magnification	Four weeks
Primary Gaze Lag	Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Baseline (after 15 minutes of lens dispense)
Primary Gaze Lag	Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Two weeks
Primary Gaze Lag	Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Four weeks
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 3 - 8:00am
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 3 - 12:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 3 - 4:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 3 - 8:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 7 - 8:00am
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 7 - 12:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 7 - 4:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 7 - 8:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 12 - 8:00am
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 12 - 12:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 12 - 4:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 12 - 8:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 26 - 8:00am
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 26 - 12:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 26 - 4:00pm
Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 26 - 8:00pm

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: David C Ardaya, OD, Golden Optometric Group; Principal Investigator: William J Bogus, OD, Office of William J. Bogus, O.D.; Principal Investigator: Bryan E Frazier, OD, Frazier Vision, Inc; Principal Investigator: Wayne Golden, OD, Golden Vision; Principal Investigator: Andrew J Sacco, OD, Sacco Eye Group; Principal Investigator: Christopher Pearson, OD, Omega Vision Center PA (DBA Sabal Eye Care)

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2019
• Primary Completion (Actual): September 24, 2019
• Study Completion (Actual): November 8, 2019

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes