Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: fanfilcon A (test)

Detailed Description

This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46100
    • Optometry Research Group (GIO) Optics Department, University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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
• Has had a self-reported visual exam in the last two years
• Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
• Has a contact lens spherical prescription between -1.00 to - 6.00
• Has a spectacle cylinder up to 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
• Has read, understood, and signed the information consent letter.
• Patient contact lens refraction should fit within the available parameters of the study lenses.
• Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
• Is willing to comply with the visit schedule

Exclusion Criteria

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

• Is not a habitual wearer of enfilcon A lenses
• Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
• Presence of clinically significant (grade 3-4) anterior segment abnormalities
• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

• Slit lamp findings that would contraindicate contact lens wear such as:

  • Pathological dry eye or associated findings
  • 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 (past or present)
  • Seborrheic eczema, 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.
• Is participating in any other type of eye related clinical or research study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: enfilcon A (habitual); Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
Experimental: fanfilcon A (test); Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.	Device: fanfilcon A (test); contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Fit - Centration	Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.	Baseline, 1 week, 2 weeks, and 4 weeks
Lens Fit - Post-blink Movement	Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.	Baseline, 1 week, 2 weeks, and 4 weeks
Lens Tightness on Push-up	Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.	Baseline, 1 week, 2 weeks, and 4 weeks
Overall Fit Acceptance	Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.	Baseline, 1 week, 2 weeks, and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort	Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.	Baseline, 1 week, 2 weeks, and 4 weeks
Dryness Overall	Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.	Baseline, 1 week, 2 weeks, and 4 weeks
Handling	Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.	Baseline, 1 week, 2 weeks, and 4 weeks
Overall Vision Satisfaction	Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.	Baseline, 1 week, 2 weeks, and 4 weeks
Overall Satisfaction	Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.	Baseline, 1 week, 2 weeks, and 4 weeks
Lens Preference Overall	Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).	1 week, 2 weeks, and 4 weeks
Wearing Times	Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.	Baseline, 1 week, 2 weeks, and 4 weeks
Conjunctival Staining	Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).	Baseline, 1 week, 2 weeks, and 4 weeks
Corneal Staining	Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.	Baseline, 1 week, 2 weeks, and 4 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Robert Montés-Mico, O.D., PhD, Optometry Research Group (GIO) University of Valencia

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-55 (CV-15-09)