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Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
filcon IV I (BC 8.6)
filcon IV I (BC 8.7)
ocufilcon D
methafilcon A (BC 8.6)
methafilcon A (BC 8.7)
somofilcon A
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 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 visual exam in the last two years.
  • Is an adapted soft CL (Contact Lens) wearer.
  • Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
  • 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.
  • Is willing to comply with the visit schedule.

Exclusion Criteria:

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

  • Has never worn contact lenses before.
  • Currently wears rigid gas permeable contact lenses.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has a CL prescription outside the range of - 1.00 to - 6.00D
  • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
  • 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 (GPC) 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 Clinic, National Autonomous University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

filcon IV I (BC 8.6) / ocufilcon D (pair one)

filcon IV I (BC 8.7) / ocufilcon D (pair two)

methafilcon A (BC 8.6) / ocufilcon D (pair three)

methafilcon A (BC 8.7) / somofilcon A (pair four)

Arm Description

Participants were randomized to a test and control lens for each pair in a contralateral design.

Participants were randomized to a test and control lens for each pair in a contralateral design.

Participants were randomized to a test and control lens for each pair in a contralateral design.

Participants were randomized to a test and control lens for each pair in a contralateral design.

Outcomes

Primary Outcome Measures

Centration - Pair One
Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Two
Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Three
Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Four
Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Post-blink Movement - Pair One
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair One
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Two
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Two
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Three
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Three
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Four
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Four
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Lens Tightness - Pair One
Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Two
Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Three
Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Four
Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Overall Fit Preference - Pair One
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Two
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Three
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Four
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2016
Last Updated
July 20, 2017
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02727816
Brief Title
Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
Official Title
Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (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 non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.
Detailed Description
This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows: Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
filcon IV I (BC 8.6) / ocufilcon D (pair one)
Arm Type
Experimental
Arm Description
Participants were randomized to a test and control lens for each pair in a contralateral design.
Arm Title
filcon IV I (BC 8.7) / ocufilcon D (pair two)
Arm Type
Experimental
Arm Description
Participants were randomized to a test and control lens for each pair in a contralateral design.
Arm Title
methafilcon A (BC 8.6) / ocufilcon D (pair three)
Arm Type
Experimental
Arm Description
Participants were randomized to a test and control lens for each pair in a contralateral design.
Arm Title
methafilcon A (BC 8.7) / somofilcon A (pair four)
Arm Type
Experimental
Arm Description
Participants were randomized to a test and control lens for each pair in a contralateral design.
Intervention Type
Device
Intervention Name(s)
filcon IV I (BC 8.6)
Intervention Description
control lens
Intervention Type
Device
Intervention Name(s)
filcon IV I (BC 8.7)
Intervention Description
control lens
Intervention Type
Device
Intervention Name(s)
ocufilcon D
Intervention Description
test lens
Intervention Type
Device
Intervention Name(s)
methafilcon A (BC 8.6)
Intervention Description
control lens
Intervention Type
Device
Intervention Name(s)
methafilcon A (BC 8.7)
Intervention Description
control lens
Intervention Type
Device
Intervention Name(s)
somofilcon A
Intervention Description
test lens
Primary Outcome Measure Information:
Title
Centration - Pair One
Description
Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Time Frame
Baseline and 1 hour
Title
Centration - Pair Two
Description
Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Time Frame
Baseline and 1 hour
Title
Centration - Pair Three
Description
Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Time Frame
Baseline and 1 hour
Title
Centration - Pair Four
Description
Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Time Frame
Baseline and 1 hour
Title
Post-blink Movement - Pair One
Description
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Time Frame
Baseline
Title
Post-blink Movement - Pair One
Description
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Time Frame
1 hour
Title
Post-blink Movement - Pair Two
Description
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Time Frame
Baseline
Title
Post-blink Movement - Pair Two
Description
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Time Frame
1 hour
Title
Post-blink Movement - Pair Three
Description
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Time Frame
Baseline
Title
Post-blink Movement - Pair Three
Description
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Time Frame
1 hour
Title
Post-blink Movement - Pair Four
Description
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Time Frame
Baseline
Title
Post-blink Movement - Pair Four
Description
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Time Frame
1 hour
Title
Lens Tightness - Pair One
Description
Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Time Frame
Baseline and 1 hour
Title
Lens Tightness - Pair Two
Description
Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Time Frame
Baseline and 1 hour
Title
Lens Tightness - Pair Three
Description
Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Time Frame
Baseline and 1 hour
Title
Lens Tightness - Pair Four
Description
Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Time Frame
Baseline and 1 hour
Title
Overall Fit Preference - Pair One
Description
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.
Time Frame
Baseline and 1 hour
Title
Overall Fit Acceptance - Pair Two
Description
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.
Time Frame
Baseline and 1 hour
Title
Overall Fit Acceptance - Pair Three
Description
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.
Time Frame
Baseline and 1 hour
Title
Overall Fit Acceptance - Pair Four
Description
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.
Time Frame
Baseline and 1 hour

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 visual exam in the last two years. Is an adapted soft CL (Contact Lens) wearer. Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive) 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. Is willing to comply with the visit schedule. Exclusion Criteria: A person will be excluded from the study if he/she: Has never worn contact lenses before. Currently wears rigid gas permeable contact lenses. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has a CL prescription outside the range of - 1.00 to - 6.00D Has a spectacle cylinder ≥1.00D of cylinder in either eye. 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 (GPC) 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.
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico D.F.
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

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