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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: fanfilcon A test lens; Device: ocufilcon D control lens; Device: etafilcon A control lens

• Registration Number: NCT04050618
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2019-06-09
• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Primary Completion: 2019-09-24
• Study Completion: 2019-11-08
• Status Verified: 2020-09
• Results First Submitted: 2020-09-24
• Results First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Results First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ocufilcon D control lens, then fanfilcon A test lens	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.
ocufilcon D control lens, then fanfilcon A test lens	ocufilcon D control 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.
etafilcon A controls, then fanfilcon A test lens	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.
etafilcon A controls, then fanfilcon A test lens	etafilcon A control 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average Wearing Time	Four weeks	Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Average Comfortable Wearing Time	Four weeks	Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.
Lens Centration	Four weeks	Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)).
Corneal Coverage	Four weeks	Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Post-Blink Movement	Four weeks	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)
Lens Tightness - Push-up Test	Four weeks	Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Overall Lens Fit Acceptance	Four weeks	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)
Rating of Lens Surface Wettability	Four weeks	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).
Presence of Film Deposits	Four weeks	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).
Number of White Spot Deposits	Four weeks	Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Primary Gaze Lag	Four weeks	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)
Comfort Throughout the Day	Day 26 - 8:00pm	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

Trial Locations

Locations (6)

Golden Optometric Group; 🇺🇸 Whittier, California, United States

Office of William J. Bogus, O.D.; 🇺🇸 Salt Lake City, Utah, United States

Frazier Vision, Inc; 🇺🇸 Tyler, Texas, United States

Omega Vision Center PA (DBA Sabal Eye Care); 🇺🇸 Longwood, Florida, United States

Golden Vision; 🇺🇸 Sarasota, Florida, United States

Sacco Eye Group; 🇺🇸 Vestal, New York, United States