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Daily Disposable Comparison Study

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ClinicalTrials.gov Identifier: NCT02094677
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : March 11, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.

Condition or disease Intervention/treatment Phase
Myopia Device: filcon II 3 Device: etafilcon A Device: nelfilcon A Phase 4

Detailed Description:
This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Daily Disposable Comparison Study
Study Start Date : March 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: filcon II 3 and etafilcon A
Participants were randomized to a test and control lens for each group in a contralateral design.
Device: filcon II 3
Participants were randomized to wear filcon II 3 test lens.
Other Name: Hydrogel Daily Disposable Contact Lens

Device: etafilcon A
Participants were randomized to wear etafilcon A control lens.
Other Names:
  • Hydrogel Daily Disposable Contact Lens
  • 1 Day Acuvue Moist

Active Comparator: filcon II 3 and nelfilcon A
Participants were randomized to a test and control lens for each group in a contralateral design.
Device: filcon II 3
Participants were randomized to wear filcon II 3 test lens.
Other Name: Hydrogel Daily Disposable Contact Lens

Device: nelfilcon A
Participants were randomized to wear nelfilcon A control lens.
Other Names:
  • Hydrogel Daily Disposable Contact Lens
  • Dailies Aqua Comfort Plus




Primary Outcome Measures :
  1. Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A [ Time Frame: Baseline visit ]

    Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire.

    (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).


  2. Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A [ Time Frame: 3 hours ]
    Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).

  3. Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A [ Time Frame: 6 hours ]
    Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).


Secondary Outcome Measures :
  1. Lens Comfort - Filcon II 3 and Etafilcon A [ Time Frame: Baseline, 3 hours, 6 hours ]
    Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).

  2. Lens Comfort - Filcon II 3 and Nelficon A [ Time Frame: Baseline, 3 hours, 6 hours ]
    Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).

  3. Lens Dryness - Filcon II 3 and Etafilcon A [ Time Frame: 3 hours and 6 hours ]
    Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).

  4. Lens Dryness - Filcon II 3 and Nelfilcon A [ Time Frame: 3 hours and 6 hours ]
    Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).

  5. Lens Handling - Filcon II 3 and Etafilcon A [ Time Frame: Baseline visit ]
    Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).

  6. Lens Handling - Filcon II 3 and Nelfilcon A [ Time Frame: Baseline visit ]
    Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).

  7. Lens Handling (Removal) - Filcon II 3 and Etafilcon A [ Time Frame: 6 hours ]
    Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).

  8. Lens Handling (Removal) - Filcon II 3 and Nelfilcon A [ Time Frame: 6 hours ]
    Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).

  9. Lens Wettability - Filcon II 3 and Etafilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).

  10. Lens Wettability - Filcon II 3 and Nelfilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).

  11. Lens Fit, Centration - Filcon II 3 and Etafilcon A [ Time Frame: Baseline ]

    The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I).

    N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior


  12. Lens Fit, Centration - Filcon II 3 and Etafilcon A [ Time Frame: 6 hours ]
    The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior

  13. Lens Fit, Centration - Filcon II 3 and Nelfilcon A [ Time Frame: Baseline ]
    The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior

  14. Lens Fit, Centration - Filcon II 3 and Nelfilcon A [ Time Frame: After 6 hours ]
    The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior

  15. Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).

  16. Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).

  17. Lens Fit, Tightness - Filcon II 3 and Etafilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).

  18. Lens Fit, Tightness - Filcon II 3 and Nelfilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).

  19. Lens Surface Deposition - Filcon II 3 and Etafilcon A [ Time Frame: 6 hour ]
    The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).

  20. Lens Surface Deposition - Filcon II 3 and Nelfilcon A [ Time Frame: 6 hour ]
    The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).

  21. High Contrast Visual Acuity - Filcon II 3 and Etafilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).

  22. High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)

  23. Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A [ Time Frame: 6 hours ]

    The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone).

    N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central


  24. Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A [ Time Frame: 6 hours ]

    The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone).

    N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central


  25. Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).

  26. Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A [ Time Frame: Baseline and 6 hours ]
    The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).



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:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
  5. Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
  6. Demonstrates an acceptable fit with the study lenses

Exclusion Criteria:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  7. Is aphakic;
  8. Has undergone refractive error surgery;

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): NCT02094677


Locations
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Canada, Ontario
Centre for Contact Lens Research
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Coopervision, Inc.

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02094677     History of Changes
Other Study ID Numbers: EX-MKTG-50
First Posted: March 24, 2014    Key Record Dates
Results First Posted: March 11, 2016
Last Update Posted: March 11, 2016
Last Verified: March 2016