Skip to main content
OpenTrials
Completed

NCT Number: NCT02094677

Daily Disposable Comparison Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

17 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

filcon II 3

Device

Participants were randomized to wear filcon II 3 test lens.

Other names: Hydrogel Daily Disposable Contact Lens

etafilcon A

Device

Participants were randomized to wear etafilcon A control lens.

Other names: Hydrogel Daily Disposable Contact Lens, 1 Day Acuvue Moist

Nelfilcon A

Device

Participants were randomized to wear nelfilcon A control lens.

Other names: Hydrogel Daily Disposable Contact Lens, Dailies Aqua Comfort Plus

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 24, 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.