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Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses

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ClinicalTrials.gov Identifier: NCT02142361
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : April 19, 2016
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.

Condition or disease Intervention/treatment Phase
Astigmatism Device: enfilcon A Not Applicable

Detailed Description:
This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Clinical Performance of Habitual Wearers of Hydrogel Toric Lenses When Refitted With Avaira Toric Silicone Hydrogel Lenses
Study Start Date : May 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: Omafilcon A/Enfilcon A
Subject's habitual hydrogel toric lenses Omafilcon A will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.
Device: enfilcon A
Silicone hydrogel toric lenses.
Other Name: enfilcon A/Silicone Hydrogel Lens

Active Comparator: Ocufilcon D/Enfilcon A
Subject's habitual hydrogel toric lenses Ocufilcon D will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.
Device: enfilcon A
Silicone hydrogel toric lenses.
Other Name: enfilcon A/Silicone Hydrogel Lens

Active Comparator: Methafilcon B/ Enfilcon A
Subject's habitual hydrogel toric lenses Methafilcon B will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.
Device: enfilcon A
Silicone hydrogel toric lenses.
Other Name: enfilcon A/Silicone Hydrogel Lens




Primary Outcome Measures :
  1. Participant's Subjective Rating for Lens Initial Comfort [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)

  2. Participant's Subjective Rating for Lens Comfort Prior to Removal [ Time Frame: Baseline and 1 week ]
    Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)

  3. Participant's Subjective Rating for Overall Lens Comfort [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)

  4. Participant's Subjective Rating for Dryness During the Day [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)

  5. Participant's Subjective Rating for Dryness Prior to Removal [ Time Frame: Baseline and 1 week ]
    Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)

  6. Participant's Subjective Rating for Overall Dryness [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)

  7. Participant's Subjective Rating for Lens Handling - Insertion [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)

  8. Participant's Subjective Rating for Overall Lens Fit Stability [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)

  9. Participant's Subjective Rating for Overall Vision Satisfaction [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)

  10. Participant's Subjective Rating for Vision Quality at Insertion [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)

  11. Participant's Subjective Rating for Vision Quality During the Day [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)

  12. Participant's Subjective Rating for Vision Quality End of the Day [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)

  13. Participant's Subjective Rating for Night Vision Quality [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)

  14. Participant's Subjective Rating for Vision Stability at Insertion [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)

  15. Participant's Subjective Rating for Vision Stability During the Day [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)

  16. Participant's Subjective Rating for Vision Stability at End of Day [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)

  17. Participant's Subjective Rating for Lens Pair Preference [ Time Frame: 1 week ]
    Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.

  18. Participant's Subjective Rating for Overall Satisfaction - Dryness [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)

  19. Participant's Subjective Rating for Overall Satisfaction - Handling [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)

  20. Participant's Subjective Rating for Overall Satisfaction - Vision [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)

  21. Participant's Subjective Rating for Overall Satisfaction - Lens Fit [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)

  22. Participant's Subjective Rating for Overall Satisfaction - Overall [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)

  23. Clinician's Objective Assessment Monocular High Contrast Distance Visual [ Time Frame: Baseline and 1 week ]
    Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.

  24. Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity [ Time Frame: Baseline and 1 week ]
    Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value

  25. Clinician's Assessment Overall Lens Stability-Right Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)

  26. Clinician's Assessment Overall Lens Stability-Left Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)

  27. Clinician's Assessment Overall Fit Acceptance- Right Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)

  28. Clinician's Assessment Overall Fit Acceptance- Left Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)

  29. Clinician's Assessment Lens Centration-Right Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm))

  30. Clinician's Assessment Lens Centration- Left Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm)

  31. Clinician's Assessment Corneal Coverage-Right Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)

  32. Clinicians Assessment Corneal Coverage-Left Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)

  33. Clinician's Assessment Post-Blink Movement- Right Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement

  34. Clinician's Assessment Post-Blink Movement-Left Eye [ Time Frame: Baseline and 1 week ]
    Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement

  35. Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye [ Time Frame: Baseline and 1 week ]
    Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.

  36. Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye [ Time Frame: Baseline and 1 week ]
    Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.

  37. Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye [ Time Frame: Baseline and 1 week ]
    Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.

  38. Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye [ Time Frame: Baseline and 1 week ]
    Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.

  39. Participant's Subjective Rating for Overall Satisfaction - Comfort [ Time Frame: Baseline and 1 week ]
    Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)



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 toric contact lens wearer
  • Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)
  • Have no less than 0.75D of astigmatism and no more than 1.75 D in both eyes.
  • 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:

  • Has a contact lens prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder less than -0.75D or more than -1.75D of cylinder in either eye.
  • Has a history of not achieving comfortable contact lens 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.

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): NCT02142361


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 Optometry Research Group (GIO) Optics Department, University of Valencia
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02142361    
Other Study ID Numbers: EX-MKTG-48
First Posted: May 20, 2014    Key Record Dates
Results First Posted: April 19, 2016
Last Update Posted: July 28, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases