Skip to main content
OpenTrials
Completed

NCT Number: NCT01966770

Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Berkeley Clinical Research Center (UCB-CRC)

Berkeley, California, 94720-2020, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pair 1 (ocufilcon D / ocufilcon D)

Device

Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)

Pair 2 (ocufilcon D / enfilcon A)

Device

Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)

Pair 3 (ocufilcon D / comfilcon A)

Device

Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)

Pair 4 (methafilcon A / methafilcon A)

Device

Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)

Pair 5 (methafilcon A / comfilcon A)

Device

Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)

Pair 6 (omafilcon A / comfilcon A)

Device

Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2013
Registry last updated
Jul 30, 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.