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Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02131402
Recruitment Status : Completed
First Posted : May 6, 2014
Results First Posted : July 22, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses

Condition or disease Intervention/treatment Phase
Myopia Device: ocufilcon D Device: omafilcon A Device: methafilcon A Not Applicable

Detailed Description:
This is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different lens materials (hydrogel vs silicone hydrogel). It is anticipated that this study will involve 2 visits, for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear the test and control lenses in a series of three short fitting comparisons.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Non-Dispensing Fitting Study Comparing the Clinical Performance of Hydrogel vs. Silicone Hydrogel Sphere Design Contact Lenses
Study Start Date : May 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: enfilcon A / omafilcon A
Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
Device: omafilcon A
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.
Other Name: Hydrogel Contact Lens

Active Comparator: enfilcon A / ocufilcon D
Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
Device: ocufilcon D
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.
Other Name: Hydrogel Contact Lens

Active Comparator: enfilcon A / methafilcon A
Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
Device: methafilcon A
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.
Other Name: Hydrogel Contact Lens




Primary Outcome Measures :
  1. Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).

  2. Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).

  3. Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).

  4. Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D [ Time Frame: Baseline ]
    Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).

  5. Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A [ Time Frame: Baseline ]
    Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).

  6. Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A [ Time Frame: Baseline ]
    Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).

  7. Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel).

  8. Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).

  9. Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A [ Time Frame: 1 hours post settling ]
    Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).

  10. Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A [ Time Frame: Baseline ]
    Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).

  11. Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D [ Time Frame: Baseline ]
    Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).

  12. Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A [ Time Frame: Baseline ]
    Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).

  13. Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).

  14. Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).

  15. Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).

  16. Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)

  17. Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)

  18. Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)

  19. Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).

  20. Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).

  21. Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)

  22. Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).

  23. Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)

  24. Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A [ Time Frame: 1 hour post settling ]
    Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)

  25. Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A [ Time Frame: Baseline ]
    Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).

  26. Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D [ Time Frame: Baseline ]
    Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)

  27. Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A [ Time Frame: Baseline ]
    Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).

  28. Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).

  29. Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).

  30. Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A [ Time Frame: 1 hour post settling ]
    Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).

  31. Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A [ Time Frame: 1 hour post settling ]
    Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)

  32. Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D [ Time Frame: 1 hour post settling ]
    Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)

  33. Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A [ Time Frame: 1 hour post settling ]
    Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 soft CL (Contact Lens) wearer
  • Has a CL spherical prescription between - 1.00 and - 10.00 (inclusive)
  • Has a spectacle cylinder up to 0.75D (Diopter) 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:

  • 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 -10.00D
  • 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 (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131402


Locations
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Spain
Optometry Research Group (GIO) Optics Department, University of Valencia
Valencia, Spain, 46100
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Robert Montés-Mico, OD MPhil PhD Optics Department, University of Valencia
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02131402    
Other Study ID Numbers: EX-MKTG-47
First Posted: May 6, 2014    Key Record Dates
Results First Posted: July 22, 2016
Last Update Posted: April 4, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases