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Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
filcon IV 1
ocufilcon D
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other 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 wearer (at least 1 week in Avaira sphere)
  • Has a contact lens spherical prescription between + 2.25 to - 8.00 (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 CL 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 Type

Experimental

Arm Label

filcon IV 1 and ocufilcon D

Arm Description

Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.

Outcomes

Primary Outcome Measures

Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.

Secondary Outcome Measures

Visual Acuity - Filcon IV 1 and Ocufilcon D
Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

Full Information

First Posted
March 30, 2015
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02406495
Brief Title
Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
Official Title
Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (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
Open label, 1-week daily disposable, dispensing study
Detailed Description
Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
filcon IV 1 and ocufilcon D
Arm Type
Experimental
Arm Description
Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.
Intervention Type
Device
Intervention Name(s)
filcon IV 1
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
ocufilcon D
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Description
Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Time Frame
Baseline and 1 Week
Title
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
Description
Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame
Baseline and 1 Week
Title
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
Description
Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Time Frame
Baseline and 1 Week
Title
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Description
Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.
Time Frame
Baseline and 1 Week
Secondary Outcome Measure Information:
Title
Visual Acuity - Filcon IV 1 and Ocufilcon D
Description
Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).
Time Frame
Baseline and 1 Week
Title
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description
Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).
Time Frame
Baseline and 1 Week
Title
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description
Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).
Time Frame
Baseline and 1 Week
Title
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description
Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).
Time Frame
Baseline and 1 Week
Title
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description
Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).
Time Frame
Baseline and 1 Week
Title
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description
Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.
Time Frame
1 Week
Title
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Description
Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame
Baseline and 1 Week
Title
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Description
Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame
Baseline and 1 Week
Title
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Description
Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame
Baseline and 1 Week
Title
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Description
Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame
Baseline and 1 Week
Title
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Description
Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame
Baseline and 1 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 wearer (at least 1 week in Avaira sphere) Has a contact lens spherical prescription between + 2.25 to - 8.00 (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 CL 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, OD MPhil PhD
Organizational Affiliation
Optometry Research Group (GIO) Optics Department, 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

Learn more about this trial

Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

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