Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: fanfilcon A; Device: senofilcon A

Detailed Description

The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Eric M. White O. D., Inc
  • Florida
    • Sarasota, Florida, United States, 34232
      • Golden Vision
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Nittany Eye Associates

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:

A person is eligible for inclusion in the study if he/she:

• Is between 18 and 40 years of age (inclusive)
• Has read, understood and signed the information consent letter
• Has had a self-reported eye exam in the last two years
• Is a spherical soft contact lens wearer
• Has a contact lens prescription that fits within the available parameters of the study lenses
• Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
• Has clear corneas and no active ocular disease
• Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
• Is willing and able to follow instructions and maintain the appointment schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; >8 hours/day)
• Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
• Is habitually using rewetting/ lubricating eye drops more than once per day
• Presents with clinically significant anterior segment abnormalities
• Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear

• Presents with slit lamp findings that would contraindicate contact lens wear such as:

  • Pathological dry eye or associated findings
  • Significant pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (or history in past year)
  • Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene
• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• Has aphakia, keratoconus or a highly irregular cornea
• Has presbyopia or has dependence on spectacles for near work over the contact lenses
• Has undergone corneal refractive surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fanfilcon A; Participants are randomized to wear fanfilcon A for two weeks during the cross over study.	Device: fanfilcon A; contact lens
Active Comparator: senofilcon A; Participants are randomized to wear senofilcon A for two weeks during the cross over study.	Device: senofilcon A; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort	Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel	2 weeks
Overall Dryness	Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness	2 weeks
Vision Quality	Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear	2 weeks
Lens Handling	Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle	2 weeks
Vision Satisfaction	Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.	2 weeks
Lens Centration	Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).	2 weeks
Conjunctival Staining	Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present; Very slight; Slight; Moderate; Severe	2 weeks
Smoothness	Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth	2 weeks
Clean Feeling	Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean	2 weeks
Lens Hydrated	Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated	2 weeks
Lens Wettability	Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable	2 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Study Director: Lyndon Jones, PhD, FAAO, Centre for Contact Lens Research

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2016
• Primary Completion (Actual): December 14, 2016
• Study Completion (Actual): December 14, 2016

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-73

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No