Skip to main content
OpenTrials
Completed

NCT Number: NCT02142361

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Valencia, 46100, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

enfilcon A

Device

Silicone hydrogel toric lenses.

Other names: enfilcon A/Silicone Hydrogel Lens

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Clinical Performance of Habitual Wearers of Hydrogel Toric Lenses When Refitted With Avaira Toric Silicone Hydrogel Lenses

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 20, 2014
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.