Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: fanfilcon A

Detailed Description

The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Hospital Contact Lens Service
  • New Jersey
    • Closter, New Jersey, United States, 07624
      • Debbie Kim
  • New York
    • New York, New York, United States, 10014
      • West Village Eyecare
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinic

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 (inclusive)
• Has had a self-reported eye exam in the last two years
• Is a habitual soft toric lens wearer
• Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
• Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)
• Has a spectacle cylinder of at least 0.75D in each eye.
• Can achieve best corrected spectacle refraction 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
• Has a contact lens refraction that fits 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:

• Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/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
  • 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.
• Is participating in any other type of eye related clinical or research study.
• Is frequently using rewetting/ lubricating eye drops (more than once per day)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: enfilcon A (habitual); All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.
ACTIVE_COMPARATOR: fanfilcon A; All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.	Device: fanfilcon A; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	High contrast distance visual acuity is measured by LogMAR.	baseline, 2 weeks, 1 month
Centration	Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).	baseline, 2 weeks, 1 month
Corneal Coverage	Corneal coverage will be assessed (yes/no)	baseline, 2 weeks, 1 month
Post-blink Movement	Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)	baseline, 2 weeks, 1 month
Fit Acceptability	Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)	baseline, 2 weeks, 1 month

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): March 21, 2017

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (ESTIMATE): October 3, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-67

Plan for Individual participant data (IPD)

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