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Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

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ClinicalTrials.gov Identifier: NCT01966770
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.

Condition or disease Intervention/treatment Phase
Myopia Device: Pair 1 (ocufilcon D / ocufilcon D) Device: Pair 2 (ocufilcon D / enfilcon A) Device: Pair 3 (ocufilcon D / comfilcon A) Device: Pair 4 (methafilcon A / methafilcon A) Device: Pair 5 (methafilcon A / comfilcon A) Device: Pair 6 (omafilcon A / comfilcon A) Not Applicable

Detailed Description:
This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: Pair 1 (ocufilcon D / ocufilcon D)
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Device: Pair 1 (ocufilcon D / ocufilcon D)
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)

Active Comparator: Pair 2 (ocufilcon D / enfilcon A)
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Device: Pair 2 (ocufilcon D / enfilcon A)
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)

Active Comparator: Pair 3 (ocufilcon D / comfilcon A)
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
Device: Pair 3 (ocufilcon D / comfilcon A)
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)

Active Comparator: Pair 4 (methafilcon A / methafilcon A)
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Device: Pair 4 (methafilcon A / methafilcon A)
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)

Active Comparator: Pair 5 (methafilcon A / comfilcon A)
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
Device: Pair 5 (methafilcon A / comfilcon A)
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)

Active Comparator: Pair 6 (omafilcon A / comfilcon A)
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Device: Pair 6 (omafilcon A / comfilcon A)
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)




Primary Outcome Measures :
  1. Visual Acuity (VA) logMAR (Habitual Lenses) [ Time Frame: Baseline ]
    Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)

  2. Visual Acuity (VA) logMAR (Study Lenses) [ Time Frame: Dispense ]
    Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)

  3. Comfort Contact Lens Insertion (Day 1 Study Lenses) [ Time Frame: Day 1 - Insertion ]
    Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)

  4. Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) [ Time Frame: Day 1 - 30 minutes ]
    Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)

  5. Comfort Contact Lens Insertion (Day 2 Study Lenses) [ Time Frame: Day 2 - Insertion ]
    Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever

  6. Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) [ Time Frame: Day 2 - 30 minutes ]
    Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever

  7. Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1) [ Time Frame: Day 1 - Insertion ]
    Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  8. Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2) [ Time Frame: Day 1 Insertion ]
    Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  9. Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3) [ Time Frame: Day 1 - Insertion ]
    Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  10. Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) [ Time Frame: Day 1 - 30 minutes ]
    Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  11. Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) [ Time Frame: Day 1 - 30 minutes ]
    Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  12. Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) [ Time Frame: Day 1 - 30 minutes ]
    Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  13. Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1) [ Time Frame: Day 2 - Insertion ]
    Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  14. Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2) [ Time Frame: Day 2 - Insertion ]
    Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  15. Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3) [ Time Frame: Day 2 - Insertion ]
    Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  16. Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) [ Time Frame: Day 2 - 30 minutes ]
    Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)

  17. Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) [ Time Frame: Day 2 - 30 minutes ]
    Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)

  18. Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) [ Time Frame: Day 2 - 30 minutes ]
    Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)

  19. Lens Fitting Characteristics, Centration (Habitual Lens) [ Time Frame: Baseline ]
    Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)

  20. Lens Fitting Characteristics, Tightness (Habitual Lens) [ Time Frame: Baseline ]
    Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)

  21. Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens) [ Time Frame: Baseline ]
    Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)

  22. Lens Fitting Characteristics, Centration (Day 1 Study Lenses) [ Time Frame: Day 1 - 30 minutes ]
    Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)

  23. Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) [ Time Frame: Day 1 - 30 minutes ]
    Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)

  24. Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) [ Time Frame: Day 1 - 30 minutes ]
    Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)

  25. Lens Fitting Characteristics, Centration (Day 2 Study Lenses) [ Time Frame: Day 2 - 30 minutes ]
    Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)

  26. Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) [ Time Frame: Day 2 - 30 minutes ]
    Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)

  27. Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) [ Time Frame: Day 2 - 30 minutes ]
    Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)

  28. Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) [ Time Frame: Day 1- 30 minutes ]
    Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)

  29. Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) [ Time Frame: Day 1- 30 minutes ]
    Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)

  30. Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) [ Time Frame: Day 1 - 30 minutes ]
    Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)

  31. Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) [ Time Frame: Day 2 - Insertion ]
    Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)

  32. Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) [ Time Frame: Day 2 - Insertion ]
    Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)

  33. Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) [ Time Frame: Day 2 - Insertion ]
    Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)

  34. Overall Ease of Lens Handling (Day 1 Study Lenses) [ Time Frame: Day 1 - After Removal ]
    Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy

  35. Overall Ease of Lens Handling (Day 2 Study Lenses) [ Time Frame: Day 2 - After Removal ]
    Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy



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:

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 contact lens wearer
  • Has a cl spherical prescription between -1.00 and -6.00 (inclusive)
  • Has a spectacle cylinder up to 0.75D (diopter) in each eye
  • Is correctable to a visual acuity of 20/25 or better in both eyes
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter
  • 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 contact lens wear (5 days per week; > 8 hours/day)
  • Has a contact lens prescription outside the range of -1.00 to -6.00D
  • Has a spectacle cylinder ≥ 1.00D of cylinder in either eye
  • Has best corrected spectacle distance vision worse than 20/25 in either eye
  • Has any systemic or topical medications that will affect ocular health
  • Has any ocular pathology or severe insufficiency of lacrimal secretion
  • Has persistent, clinically significant corneal or conjunctival staining
  • Has active neovascularization or any central corneal scars
  • Is aphakic
  • Is presbyopic
  • Has undergone corneal refractive surgery
  • Is participating in any other type of eye related conical 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): NCT01966770


Locations
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United States, California
University of California, Berkeley Clinical Research Center (UCB-CRC)
Berkeley, California, United States, 94720-2020
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Meng Lin, OD PhD FAAO CRC-UC Berkeley

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01966770     History of Changes
Other Study ID Numbers: EX-MKTG-44
First Posted: October 22, 2013    Key Record Dates
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015