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OpenTrials
Completed

NCT Number: NCT02060539

Multicenter Dispensing Study of Biofinity Lenses in Extended Range

To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.

Completed

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Key information

Conditions

Myopia Eye Diseases Hyperopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CCLR, University of Waterloo, Waterloo, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Has had an oculo-visual examination in the last two years
  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction
  • Currently wears soft contact lenses
  • They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
  • Has clear corneas and no active ocular disease
  • Demonstrates an acceptable fit with the study lenses.

Exclusion criteria

  • Has any systemic disease affecting ocular health
  • Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
  • Have any active ocular disease and/or infection that would contraindicate contact lens wear.
  • Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
  • Has worn gas permeable contact lenses within the last month.
  • Is aphakic
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of clinical research study
  • Female who is currently pregnant or is breast-feeding.

Treatment and study plan

Biofinity XR

Device

Primary outcomes

  1. Dryness (During Day and Dryness at Night)

    Time frame: Baseline

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.

  2. Dryness (During Day)

    Time frame: Dispense

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  3. Dryness (During Day and Dryness at Night)

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.

  4. Comfort (Insertion, End of Day, Overall)

    Time frame: Baseline

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.

  5. Comfort (Insertion)

    Time frame: Dispense

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  6. Comfort (Insertion, End of Day, Overall)

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.

  7. Ghosting (Multiple Images)

    Time frame: Baseline

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.

  8. Ghosting (Multiple Images)

    Time frame: Dispense

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  9. Ghosting (Multiple Images)

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.

  10. Hazing (Blurred Edges)

    Time frame: Baseline

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.

  11. Hazing (Blurred Edges)

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.

  12. Vision Quality (During Day and at Night)

    Time frame: Baseline

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.

  13. Vision Quality (During Day)

    Time frame: Dispense

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  14. Vision Quality (During Day and at Night)

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.

  15. Handling (Insertion, Removal, Overall)

    Time frame: Baseline

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.

  16. Handling (Insertion, Removal, Overall)

    Time frame: 2 weeks

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.

  17. Overall Satisfaction of Comfort, Vision, Handling

    Time frame: Dispense

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  18. Overall Satisfaction of Comfort, Vision, Handling

    Time frame: Baseline

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.

  19. Overall Satisfaction of Comfort, Vision, Handling

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.

  20. Comfort Preference

    Time frame: Dispense

    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  21. Comfort Preference

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.

  22. Vision Preference

    Time frame: Dispense

    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  23. Vision Preference

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.

  24. Handling Preference

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.

  25. Overall Preference

    Time frame: Dispense

    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  26. Overall Preference

    Time frame: 2 Weeks

    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.

Secondary outcomes

  1. Lens Centration - Habitual Lenses

    Time frame: Baseline

    Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.

  2. Lens Centration

    Time frame: Dispense

    Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.

  3. Lens Centration

    Time frame: 2 Weeks

    Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.

  4. Lens Movement - Habitual Lenses

    Time frame: Baseline

    Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.

  5. Lens Movement

    Time frame: Dispense

    Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  6. Lens Movement

    Time frame: 2 Weeks

    Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.

  7. Overall Fit Acceptance

    Time frame: Baseline

    Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.

  8. Overall Fit Acceptance

    Time frame: Dispense

    Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  9. Overall Fit Acceptance

    Time frame: 2 Weeks

    Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.

  10. Visual Acuity

    Time frame: Baseline

    Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.

  11. Visual Acuity

    Time frame: Dispense

    Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  12. Visual Acuity

    Time frame: 2 Weeks

    Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.

  13. Anterior Ocular Physiological Response

    Time frame: Baseline

    Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.

  14. Anterior Ocular Physiological Response

    Time frame: 2 Weeks

    Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.

  15. Average Wearing Time

    Time frame: Baseline

    Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.

  16. Average Wearing Time

    Time frame: 2 Weeks

    Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2014
Registry last updated
Dec 11, 2017

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.

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