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Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere

Primary Purpose

Myopia

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

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted Avaira sphere contact lens (CL) wearer (at least 1 week in Avaira sphere)
  • Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive)
  • Has a spectacle cylinder up to 0.75D 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:

  • Is not a habitual wearer of Avaira sphere lenses
  • Has a 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 2-4) 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

enfilcon A

somofilcon A

Arm Description

All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens

All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens

Outcomes

Primary Outcome Measures

Visual Acuity - Enfilcon A and Somofilcon A
Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Subjective Assessments. - Enfilcon A and Somofilcon A
Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)

Secondary Outcome Measures

Full Information

First Posted
September 23, 2014
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02248727
Brief Title
Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere
Official Title
Clinical Performance of Existing Wearers of Avaira Sphere (Enfilcon A) Following a Refit With Clariti Elite Sphere (Somofilcon A) Lenses for 4 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (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
The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear.
Detailed Description
This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira sphere lenses following a refit with Clariti Elite sphere lenses. Subject's habitual Avaira sphere lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti Elite sphere lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
enfilcon A
Arm Type
Active Comparator
Arm Description
All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
Arm Title
somofilcon A
Arm Type
Experimental
Arm Description
All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
Intervention Type
Device
Intervention Name(s)
somofilcon A
Intervention Description
somofilcon A lens
Primary Outcome Measure Information:
Title
Visual Acuity - Enfilcon A and Somofilcon A
Description
Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Time Frame
Baseline, 1 Week, 2 Week, 4 Week
Title
Subjective Assessments. - Enfilcon A and Somofilcon A
Description
Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)
Time Frame
Baseline, 1 Week, 2 Week, 4 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is between 18 and 40 years of age (inclusive) Has had a self-reported visual exam in the last two years Is an adapted Avaira sphere contact lens (CL) wearer (at least 1 week in Avaira sphere) Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive) Has a spectacle cylinder up to 0.75D 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: Is not a habitual wearer of Avaira sphere lenses Has a 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 2-4) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Montés-Mico, O.D.
Organizational Affiliation
Optometry Research Group (GIO) University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Research Group (GIO) Optics Department, University of Valencia
City
Valencia
ZIP/Postal Code
46100
Country
Spain

12. IPD Sharing Statement

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Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere

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