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

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fanfilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Hospital Contact Lens Service
  • Debbie Kim
  • West Village Eyecare
  • Spokane Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

enfilcon A (habitual)

fanfilcon A

Arm Description

All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

Outcomes

Primary Outcome Measures

Visual Acuity
High contrast distance visual acuity is measured by LogMAR.
Centration
Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).
Corneal Coverage
Corneal coverage will be assessed (yes/no)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
September 29, 2016
Last Updated
March 13, 2018
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02921412
Brief Title
Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
Official Title
Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
March 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enfilcon A (habitual)
Arm Type
No Intervention
Arm Description
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.
Arm Title
fanfilcon A
Arm Type
Active Comparator
Arm Description
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.
Intervention Type
Device
Intervention Name(s)
fanfilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
High contrast distance visual acuity is measured by LogMAR.
Time Frame
baseline, 2 weeks, 1 month
Title
Centration
Description
Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).
Time Frame
baseline, 2 weeks, 1 month
Title
Corneal Coverage
Description
Corneal coverage will be assessed (yes/no)
Time Frame
baseline, 2 weeks, 1 month
Title
Post-blink Movement
Description
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)
Time Frame
baseline, 2 weeks, 1 month
Title
Fit Acceptability
Description
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)
Time Frame
baseline, 2 weeks, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Hospital Contact Lens Service
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Debbie Kim
City
Closter
State/Province
New Jersey
ZIP/Postal Code
07624
Country
United States
Facility Name
West Village Eyecare
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Spokane Eye Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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