Myopia
Conditions
Brief summary
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Detailed description
Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.
Interventions
DEVICEcomfilcon A
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
DEVICElotrafilcon B
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Is between 18 and 40 years of age (inclusive) * Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study * Has had a self-reported visual exam in the last two years * Is an adapted soft CL wearer * Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive) * Has less than 0.75D spectacle cylinder 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 (at least 40 hrs per week) * Is willing to comply with the visit schedule
Exclusion criteria
* Has never worn contact lenses before * Currently wears rigid gas permeable contact lenses * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has a contact lens prescription outside the range of - 1.00 to -9.00D * Has a spectacle cylinder greater than -0.50D of cylinder in either eye * Has best corrected spectacle distance vision worse then 20/25 in either eye * Has any systemic disease affecting ocular health * Is using 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 clinical or research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Preference for Handling | 4 weeks | Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual). |
| Vision Satisfaction | 2 weeks | Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied) |
| Eye Whiteness/Redness | 2 weeks | Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White) |
| Overall Sensation of Moistness | 2 weeks | Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor. |
| Overall Sensation of Smoothness | 2 weeks | Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor. |
| Overall Comfort Satisfaction | 2 weeks | Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied |
| Overall Dryness Satisfaction | 2 weeks | Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied |
| Overall Handling Satisfaction | 2 weeks | Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied |
| Overall Vision Satisfaction | 2 weeks | Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied |
| Overall Satisfaction | 2 weeks | Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied |
| Lens Preference, Pair 1 Comfilcon A | 2 weeks | Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual) |
| Lens Preference, Pair 1 Lotrafilcon B | 2 weeks | Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual ) |
| Rewetting Drops | 4 weeks | Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops). |
| Lens Preference | 4 weeks | Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2). |
| Lens Preference Comfort, Dryness, Vision and Overall. | 4 weeks | Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual). |
| Comfort at Insertion | Dispense | Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel). |
| Visual Quality | Dispense | Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision) |
| Average Daily Wearing Time | 2 weeks | Participants measure of average daily wear time for study lenses at 2 Weeks. |
| Comfortable Wearing Time | 2 weeks | Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time) |
| Comfort | 2 weeks | Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel). |
| Dryness | 2 weeks | Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness). |
| Handling | 2 weeks | Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Visual Acuity logMAR | Dispense | Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart |
| Surface Wetting | Dispense | Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= \> 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps) |
| Surface Deposition | Dispense | Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4) |
| Centration | Dispense | Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal) |
| Corneal Coverage | Dispense | Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering) |
| Post Blink Movement | Dispense | Assessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement) |
| Push Up Test | Dispense | Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement) |
| Overall Fit Acceptance | Dispense | Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect) |
| Rewetting Drops | 2 weeks | Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops). |
| Likelihood of Switching From Habitual Lens to Study Lens | 4 weeks | Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely |
| Likelihood to Continue Wearing the Study Lens | 4 weeks | Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely |
| Participant Recommendation of a Study Lens | 4 weeks | Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2). |
| Participant Likelihood of Recommendation of a Study Lens | 4 weeks | Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely). |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses. | Dispense | The number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, \>3) |
Countries
United States
Participant flow
Recruitment details
This was a 1 month, cross-over dispensing study conducted at 6 clinical sites in the US. 63 subjects were enrolled, 12 were discontinued and 51 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Comfilcon A Then Lotrafilcon B Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period. | 37 |
| Lotrafilcon B Then Comfilcon A Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period. | 26 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Physician Decision | 3 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Comfilcon A Then Lotrafilcon B | Lotrafilcon B Then Comfilcon A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 26 Participants | 63 Participants |
| Region of Enrollment United States | 37 participants | 26 participants | 63 participants |
| Sex: Female, Male Female | 23 Participants | 15 Participants | 38 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 1 / 63 | 0 / 63 |
Outcome results
Primary
Average Daily Wearing Time
Participants measure of average daily wear time for study lenses at 2 Weeks.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Average Daily Wearing Time | 13.72 hours | Standard Deviation 2.66 |
| Lotrafilcon B | Average Daily Wearing Time | 13.82 hours | Standard Deviation 2.95 |
Primary
Average Daily Wearing Time
Participants measure of average daily wear time for study lenses at 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Average Daily Wearing Time | 13.57 hours | Standard Deviation 2.88 |
| Lotrafilcon B | Average Daily Wearing Time | 13.91 hours | Standard Deviation 2.82 |
Primary
Comfort
Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Comfort | Insertion | 8.70 units on a scale | Standard Deviation 1.62 |
| Comfilcon A | Comfort | Prior to Removal | 7.38 units on a scale | Standard Deviation 2 |
| Comfilcon A | Comfort | During Day | 8.29 units on a scale | Standard Deviation 1.79 |
| Comfilcon A | Comfort | Overall | 8.07 units on a scale | Standard Deviation 1.79 |
| Lotrafilcon B | Comfort | During Day | 7.77 units on a scale | Standard Deviation 1.8 |
| Lotrafilcon B | Comfort | Insertion | 8.12 units on a scale | Standard Deviation 1.83 |
| Lotrafilcon B | Comfort | Overall | 7.56 units on a scale | Standard Deviation 1.87 |
| Lotrafilcon B | Comfort | Prior to Removal | 6.58 units on a scale | Standard Deviation 2.2 |
Primary
Comfort
Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Comfort | Insertion | 8.78 units on a scale | Standard Deviation 1.48 |
| Comfilcon A | Comfort | During Day | 8.29 units on a scale | Standard Deviation 1.63 |
| Comfilcon A | Comfort | Prior to Removal | 7.31 units on a scale | Standard Deviation 2.2 |
| Comfilcon A | Comfort | Overall | 8.28 units on a scale | Standard Deviation 1.58 |
| Lotrafilcon B | Comfort | Overall | 7.84 units on a scale | Standard Deviation 1.75 |
| Lotrafilcon B | Comfort | Insertion | 8.35 units on a scale | Standard Deviation 1.68 |
| Lotrafilcon B | Comfort | Prior to Removal | 7.00 units on a scale | Standard Deviation 1.95 |
| Lotrafilcon B | Comfort | During Day | 8.09 units on a scale | Standard Deviation 1.76 |
Primary
Comfortable Wearing Time
Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Comfortable Wearing Time | 11.07 hours | Standard Deviation 3.87 |
| Lotrafilcon B | Comfortable Wearing Time | 11.14 hours | Standard Deviation 3.72 |
Primary
Comfortable Wearing Time
Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Comfortable Wearing Time | 11.07 hours | Standard Deviation 3.33 |
| Lotrafilcon B | Comfortable Wearing Time | 10.67 hours | Standard Deviation 4.15 |
Primary
Comfort at Insertion
Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Comfort at Insertion | 9.21 units on a scale | Standard Deviation 1.06 |
| Lotrafilcon B | Comfort at Insertion | 8.22 units on a scale | Standard Deviation 1.98 |
Primary
Dryness
Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Dryness | During Day | 8.34 units on a scale | Standard Deviation 1.72 |
| Comfilcon A | Dryness | Prior to Removal | 7.38 units on a scale | Standard Deviation 1.77 |
| Comfilcon A | Dryness | Overall | 8.04 units on a scale | Standard Deviation 1.79 |
| Lotrafilcon B | Dryness | During Day | 7.70 units on a scale | Standard Deviation 2.04 |
| Lotrafilcon B | Dryness | Prior to Removal | 6.74 units on a scale | Standard Deviation 2.31 |
| Lotrafilcon B | Dryness | Overall | 7.39 units on a scale | Standard Deviation 2.05 |
Primary
Dryness
Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Dryness | During Day | 8.19 units on a scale | Standard Deviation 1.76 |
| Comfilcon A | Dryness | Prior to Removal | 7.21 units on a scale | Standard Deviation 2.27 |
| Comfilcon A | Dryness | Overall | 7.97 units on a scale | Standard Deviation 1.9 |
| Lotrafilcon B | Dryness | During Day | 7.95 units on a scale | Standard Deviation 1.71 |
| Lotrafilcon B | Dryness | Prior to Removal | 6.89 units on a scale | Standard Deviation 1.93 |
| Lotrafilcon B | Dryness | Overall | 7.60 units on a scale | Standard Deviation 1.7 |
Primary
Eye Whiteness/Redness
Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Eye Whiteness/Redness | 8.69 units on a scale | Standard Deviation 1.9 |
| Lotrafilcon B | Eye Whiteness/Redness | 8.72 units on a scale | Standard Deviation 1.61 |
Primary
Eye Whiteness/Redness
Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Eye Whiteness/Redness | 8.93 units on a scale | Standard Deviation 1.28 |
| Lotrafilcon B | Eye Whiteness/Redness | 8.53 units on a scale | Standard Deviation 1.91 |
Primary
Handling
Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Handling | Insertion/Removal | 9.19 units on a scale | Standard Deviation 1.48 |
| Comfilcon A | Handling | Overall | 9.21 units on a scale | Standard Deviation 1.42 |
| Lotrafilcon B | Handling | Insertion/Removal | 9.37 units on a scale | Standard Deviation 0.9 |
| Lotrafilcon B | Handling | Overall | 9.39 units on a scale | Standard Deviation 0.9 |
Primary
Handling
Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Handling | Insertion/Removal | 9.21 units on a scale | Standard Deviation 1.26 |
| Comfilcon A | Handling | Overall | 9.27 units on a scale | Standard Deviation 1.17 |
| Lotrafilcon B | Handling | Insertion/Removal | 9.25 units on a scale | Standard Deviation 1.31 |
| Lotrafilcon B | Handling | Overall | 9.25 units on a scale | Standard Deviation 1.31 |
Primary
Lens Preference
Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Lens Preference | Dryness | 32 participants |
| Comfilcon A | Lens Preference | Vision | 33 participants |
| Comfilcon A | Lens Preference | Handling | 30 participants |
| Comfilcon A | Lens Preference | Overall | 32 participants |
| Comfilcon A | Lens Preference | Comfort | 32 participants |
| Lotrafilcon B | Lens Preference | Overall | 21 participants |
| Lotrafilcon B | Lens Preference | Comfort | 21 participants |
| Lotrafilcon B | Lens Preference | Dryness | 21 participants |
| Lotrafilcon B | Lens Preference | Handling | 23 participants |
| Lotrafilcon B | Lens Preference | Vision | 20 participants |
Primary
Lens Preference Comfort, Dryness, Vision and Overall.
Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Lens Preference Comfort, Dryness, Vision and Overall. | Comfort | 24 participants |
| Comfilcon A | Lens Preference Comfort, Dryness, Vision and Overall. | Dryness | 23 participants |
| Comfilcon A | Lens Preference Comfort, Dryness, Vision and Overall. | Vision | 23 participants |
| Comfilcon A | Lens Preference Comfort, Dryness, Vision and Overall. | Overall | 22 participants |
| Lotrafilcon B | Lens Preference Comfort, Dryness, Vision and Overall. | Overall | 10 participants |
| Lotrafilcon B | Lens Preference Comfort, Dryness, Vision and Overall. | Comfort | 10 participants |
| Lotrafilcon B | Lens Preference Comfort, Dryness, Vision and Overall. | Vision | 10 participants |
| Lotrafilcon B | Lens Preference Comfort, Dryness, Vision and Overall. | Dryness | 11 participants |
| Habitual Lens | Lens Preference Comfort, Dryness, Vision and Overall. | Overall | 21 participants |
| Habitual Lens | Lens Preference Comfort, Dryness, Vision and Overall. | Dryness | 19 participants |
| Habitual Lens | Lens Preference Comfort, Dryness, Vision and Overall. | Vision | 20 participants |
| Habitual Lens | Lens Preference Comfort, Dryness, Vision and Overall. | Comfort | 19 participants |
Primary
Lens Preference for Handling
Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comfilcon A | Lens Preference for Handling | 21 participants |
| Lotrafilcon B | Lens Preference for Handling | 14 participants |
| Habitual Lens | Lens Preference for Handling | 19 participants |
Primary
Lens Preference, Pair 1 Comfilcon A
Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Lens Preference, Pair 1 Comfilcon A | Dryness | 26 participants |
| Comfilcon A | Lens Preference, Pair 1 Comfilcon A | Vision | 27 participants |
| Comfilcon A | Lens Preference, Pair 1 Comfilcon A | Handling | 29 participants |
| Comfilcon A | Lens Preference, Pair 1 Comfilcon A | Overall | 26 participants |
| Comfilcon A | Lens Preference, Pair 1 Comfilcon A | Comfort | 26 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Comfilcon A | Overall | 32 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Comfilcon A | Comfort | 32 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Comfilcon A | Dryness | 32 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Comfilcon A | Handling | 29 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Comfilcon A | Vision | 31 participants |
Primary
Lens Preference, Pair 1 Lotrafilcon B
Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Lens Preference, Pair 1 Lotrafilcon B | Dryness | 18 participants |
| Comfilcon A | Lens Preference, Pair 1 Lotrafilcon B | Vision | 23 participants |
| Comfilcon A | Lens Preference, Pair 1 Lotrafilcon B | Handling | 25 participants |
| Comfilcon A | Lens Preference, Pair 1 Lotrafilcon B | Overall | 19 participants |
| Comfilcon A | Lens Preference, Pair 1 Lotrafilcon B | Comfort | 19 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Lotrafilcon B | Overall | 38 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Lotrafilcon B | Comfort | 38 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Lotrafilcon B | Dryness | 39 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Lotrafilcon B | Handling | 32 participants |
| Lotrafilcon B | Lens Preference, Pair 1 Lotrafilcon B | Vision | 31 participants |
Primary
Overall Comfort Satisfaction
Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Comfort Satisfaction | Completely Satisfied | 30 participants |
| Comfilcon A | Overall Comfort Satisfaction | Somewhat Satisfied | 18 participants |
| Comfilcon A | Overall Comfort Satisfaction | Somewhat Dissatisfied | 9 participants |
| Comfilcon A | Overall Comfort Satisfaction | Completely Dissatisfied | 1 participants |
| Lotrafilcon B | Overall Comfort Satisfaction | Completely Dissatisfied | 4 participants |
| Lotrafilcon B | Overall Comfort Satisfaction | Completely Satisfied | 20 participants |
| Lotrafilcon B | Overall Comfort Satisfaction | Somewhat Dissatisfied | 7 participants |
| Lotrafilcon B | Overall Comfort Satisfaction | Somewhat Satisfied | 26 participants |
Primary
Overall Comfort Satisfaction
Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Comfort Satisfaction | Completely Satisfied | 28 participants |
| Comfilcon A | Overall Comfort Satisfaction | Somewhat Satisfied | 21 participants |
| Comfilcon A | Overall Comfort Satisfaction | Somewhat Dissatisfied | 5 participants |
| Comfilcon A | Overall Comfort Satisfaction | Completely Dissatisfied | 2 participants |
| Lotrafilcon B | Overall Comfort Satisfaction | Completely Dissatisfied | 4 participants |
| Lotrafilcon B | Overall Comfort Satisfaction | Completely Satisfied | 20 participants |
| Lotrafilcon B | Overall Comfort Satisfaction | Somewhat Dissatisfied | 8 participants |
| Lotrafilcon B | Overall Comfort Satisfaction | Somewhat Satisfied | 25 participants |
Primary
Overall Dryness Satisfaction
Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Dryness Satisfaction | Completely Satisfied | 24 participants |
| Comfilcon A | Overall Dryness Satisfaction | Somewhat Satisfied | 23 participants |
| Comfilcon A | Overall Dryness Satisfaction | Somewhat Dissatisfied | 9 participants |
| Comfilcon A | Overall Dryness Satisfaction | Completely Dissatisfied | 2 participants |
| Lotrafilcon B | Overall Dryness Satisfaction | Completely Dissatisfied | 4 participants |
| Lotrafilcon B | Overall Dryness Satisfaction | Completely Satisfied | 20 participants |
| Lotrafilcon B | Overall Dryness Satisfaction | Somewhat Dissatisfied | 11 participants |
| Lotrafilcon B | Overall Dryness Satisfaction | Somewhat Satisfied | 22 participants |
Primary
Overall Dryness Satisfaction
Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Dryness Satisfaction | Completely Satisfied | 22 participants |
| Comfilcon A | Overall Dryness Satisfaction | Somewhat Satisfied | 27 participants |
| Comfilcon A | Overall Dryness Satisfaction | Somewhat Dissatisfied | 5 participants |
| Comfilcon A | Overall Dryness Satisfaction | Completely Dissatisfied | 2 participants |
| Lotrafilcon B | Overall Dryness Satisfaction | Completely Dissatisfied | 6 participants |
| Lotrafilcon B | Overall Dryness Satisfaction | Completely Satisfied | 21 participants |
| Lotrafilcon B | Overall Dryness Satisfaction | Somewhat Dissatisfied | 8 participants |
| Lotrafilcon B | Overall Dryness Satisfaction | Somewhat Satisfied | 22 participants |
Primary
Overall Handling Satisfaction
Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Handling Satisfaction | Completely Satisfied | 49 participants |
| Comfilcon A | Overall Handling Satisfaction | Completely Dissatisfied | 0 participants |
| Comfilcon A | Overall Handling Satisfaction | Somewhat Satisfied | 6 participants |
| Comfilcon A | Overall Handling Satisfaction | Somewhat Dissatisfied | 3 participants |
| Lotrafilcon B | Overall Handling Satisfaction | Somewhat Satisfied | 13 participants |
| Lotrafilcon B | Overall Handling Satisfaction | Completely Dissatisfied | 0 participants |
| Lotrafilcon B | Overall Handling Satisfaction | Completely Satisfied | 43 participants |
| Lotrafilcon B | Overall Handling Satisfaction | Somewhat Dissatisfied | 1 participants |
Primary
Overall Handling Satisfaction
Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Handling Satisfaction | Completely Satisfied | 42 participants |
| Comfilcon A | Overall Handling Satisfaction | Somewhat Satisfied | 12 participants |
| Comfilcon A | Overall Handling Satisfaction | Somewhat Dissatisfied | 1 participants |
| Comfilcon A | Overall Handling Satisfaction | Completely Dissatisfied | 1 participants |
| Lotrafilcon B | Overall Handling Satisfaction | Completely Dissatisfied | 0 participants |
| Lotrafilcon B | Overall Handling Satisfaction | Completely Satisfied | 44 participants |
| Lotrafilcon B | Overall Handling Satisfaction | Somewhat Dissatisfied | 2 participants |
| Lotrafilcon B | Overall Handling Satisfaction | Somewhat Satisfied | 11 participants |
Primary
Overall Satisfaction
Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Satisfaction | Somewhat Satisfied | 22 participants |
| Comfilcon A | Overall Satisfaction | Completely Satisfied | 28 participants |
| Comfilcon A | Overall Satisfaction | Somewhat Dissatisfied | 5 participants |
| Comfilcon A | Overall Satisfaction | Completely Dissatisfied | 1 participants |
| Lotrafilcon B | Overall Satisfaction | Completely Dissatisfied | 2 participants |
| Lotrafilcon B | Overall Satisfaction | Completely Satisfied | 23 participants |
| Lotrafilcon B | Overall Satisfaction | Somewhat Satisfied | 23 participants |
| Lotrafilcon B | Overall Satisfaction | Somewhat Dissatisfied | 9 participants |
Primary
Overall Satisfaction
Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Satisfaction | Completely Satisfied | 30 participants |
| Comfilcon A | Overall Satisfaction | Somewhat Dissatisfied | 9 participants |
| Comfilcon A | Overall Satisfaction | Somewhat Satisfied | 18 participants |
| Comfilcon A | Overall Satisfaction | Completely Dissatisfied | 1 participants |
| Lotrafilcon B | Overall Satisfaction | Somewhat Satisfied | 26 participants |
| Lotrafilcon B | Overall Satisfaction | Completely Satisfied | 20 participants |
| Lotrafilcon B | Overall Satisfaction | Completely Dissatisfied | 4 participants |
| Lotrafilcon B | Overall Satisfaction | Somewhat Dissatisfied | 7 participants |
Primary
Overall Sensation of Moistness
Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Sensation of Moistness | Good | 25 participants |
| Comfilcon A | Overall Sensation of Moistness | Fair | 6 participants |
| Comfilcon A | Overall Sensation of Moistness | Average | 9 participants |
| Comfilcon A | Overall Sensation of Moistness | Poor | 1 participants |
| Comfilcon A | Overall Sensation of Moistness | Excellent | 17 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Poor | 2 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Excellent | 12 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Good | 24 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Average | 12 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Fair | 7 participants |
Primary
Overall Sensation of Moistness
Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Sensation of Moistness | Good | 25 participants |
| Comfilcon A | Overall Sensation of Moistness | Fair | 4 participants |
| Comfilcon A | Overall Sensation of Moistness | Average | 9 participants |
| Comfilcon A | Overall Sensation of Moistness | Poor | 1 participants |
| Comfilcon A | Overall Sensation of Moistness | Excellent | 17 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Poor | 3 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Excellent | 13 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Good | 21 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Average | 14 participants |
| Lotrafilcon B | Overall Sensation of Moistness | Fair | 6 participants |
Primary
Overall Sensation of Smoothness
Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Sensation of Smoothness | Good | 23 participants |
| Comfilcon A | Overall Sensation of Smoothness | Fair | 3 participants |
| Comfilcon A | Overall Sensation of Smoothness | Average | 8 participants |
| Comfilcon A | Overall Sensation of Smoothness | Poor | 0 participants |
| Comfilcon A | Overall Sensation of Smoothness | Excellent | 22 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Poor | 1 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Excellent | 18 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Good | 16 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Average | 16 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Fair | 6 participants |
Primary
Overall Sensation of Smoothness
Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Sensation of Smoothness | Fair | 5 participants |
| Comfilcon A | Overall Sensation of Smoothness | Poor | 0 participants |
| Comfilcon A | Overall Sensation of Smoothness | Excellent | 23 participants |
| Comfilcon A | Overall Sensation of Smoothness | Good | 17 participants |
| Comfilcon A | Overall Sensation of Smoothness | Average | 13 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Average | 12 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Good | 20 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Poor | 3 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Fair | 1 participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Excellent | 21 participants |
Primary
Overall Vision Satisfaction
Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Vision Satisfaction | Completely Satisfied | 45 participants |
| Comfilcon A | Overall Vision Satisfaction | Somewhat Satisfied | 8 participants |
| Comfilcon A | Overall Vision Satisfaction | Somewhat Dissatisfied | 2 participants |
| Comfilcon A | Overall Vision Satisfaction | Completely Dissatisfied | 1 participants |
| Lotrafilcon B | Overall Vision Satisfaction | Completely Dissatisfied | 4 participants |
| Lotrafilcon B | Overall Vision Satisfaction | Completely Satisfied | 38 participants |
| Lotrafilcon B | Overall Vision Satisfaction | Somewhat Dissatisfied | 3 participants |
| Lotrafilcon B | Overall Vision Satisfaction | Somewhat Satisfied | 12 participants |
Primary
Overall Vision Satisfaction
Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Vision Satisfaction | Completely Satisfied | 43 participants |
| Comfilcon A | Overall Vision Satisfaction | Somewhat Satisfied | 12 participants |
| Comfilcon A | Overall Vision Satisfaction | Somewhat Dissatisfied | 1 participants |
| Comfilcon A | Overall Vision Satisfaction | Completely Dissatisfied | 2 participants |
| Lotrafilcon B | Overall Vision Satisfaction | Completely Dissatisfied | 3 participants |
| Lotrafilcon B | Overall Vision Satisfaction | Completely Satisfied | 35 participants |
| Lotrafilcon B | Overall Vision Satisfaction | Somewhat Dissatisfied | 5 participants |
| Lotrafilcon B | Overall Vision Satisfaction | Somewhat Satisfied | 14 participants |
Primary
Rewetting Drops
Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Rewetting Drops | Uses | 46 participants |
| Comfilcon A | Rewetting Drops | Does Not Use | 10 participants |
| Lotrafilcon B | Rewetting Drops | Uses | 48 participants |
| Lotrafilcon B | Rewetting Drops | Does Not Use | 9 participants |
Primary
Vision Satisfaction
Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Vision Satisfaction | 9.13 units on a scale | Standard Deviation 1.6 |
| Lotrafilcon B | Vision Satisfaction | 8.51 units on a scale | Standard Deviation 1.94 |
Primary
Vision Satisfaction
Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Vision Satisfaction | 9.10 units on a scale | Standard Deviation 1.83 |
| Lotrafilcon B | Vision Satisfaction | 8.82 units on a scale | Standard Deviation 1.69 |
Primary
Visual Quality
Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Visual Quality | 9.27 units on a scale | Standard Deviation 1.02 |
| Lotrafilcon B | Visual Quality | 8.87 units on a scale | Standard Deviation 1.89 |
Secondary
Binocular Visual Acuity logMAR
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Binocular Visual Acuity logMAR | -0.052 logMAR | Standard Deviation 0.048 |
| Lotrafilcon B | Binocular Visual Acuity logMAR | -0.054 logMAR | Standard Deviation 0.05 |
Secondary
Binocular Visual Acuity logMAR
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Binocular Visual Acuity logMAR | -0.036 logMAR | Standard Deviation 0.076 |
| Lotrafilcon B | Binocular Visual Acuity logMAR | -0.037 logMAR | Standard Deviation 0.048 |
Secondary
Binocular Visual Acuity logMAR
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Time frame: 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Binocular Visual Acuity logMAR | -0.052 logMAR | Standard Deviation 0.0063 |
| Lotrafilcon B | Binocular Visual Acuity logMAR | -0.047 logMAR | Standard Deviation 0.058 |
Secondary
Centration
Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)
Time frame: Dispense
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Centration | Optimal Centration | 116 lenses |
| Comfilcon A | Centration | Not Optimal Centration | 10 lenses |
| Lotrafilcon B | Centration | Optimal Centration | 109 lenses |
| Lotrafilcon B | Centration | Not Optimal Centration | 11 lenses |
Secondary
Centration
Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Centration | Optimal Centration | 110 lenses |
| Comfilcon A | Centration | Not Optimal Centration | 6 lenses |
| Lotrafilcon B | Centration | Optimal Centration | 100 lenses |
| Lotrafilcon B | Centration | Not Optimal Centration | 14 lenses |
Secondary
Centration
Assessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)
Time frame: 4 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Centration | Optimal Centration | 100 lenses |
| Comfilcon A | Centration | Not Optimal Centration | 10 lenses |
| Lotrafilcon B | Centration | Optimal Centration | 106 lenses |
| Lotrafilcon B | Centration | Not Optimal Centration | 8 lenses |
Secondary
Corneal Coverage
Assessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Corneal Coverage | Normal Coverage | 116 lenses |
| Comfilcon A | Corneal Coverage | Not Covering | 0 lenses |
| Lotrafilcon B | Corneal Coverage | Not Covering | 1 lenses |
| Lotrafilcon B | Corneal Coverage | Normal Coverage | 113 lenses |
Secondary
Corneal Coverage
Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)
Time frame: Dispense
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Corneal Coverage | Normal Coverage | 126 lenses |
| Comfilcon A | Corneal Coverage | Not Covering | 0 lenses |
| Lotrafilcon B | Corneal Coverage | Normal Coverage | 118 lenses |
| Lotrafilcon B | Corneal Coverage | Not Covering | 2 lenses |
Secondary
Corneal Coverage
Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)
Time frame: 4 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Corneal Coverage | Normal Coverage | 110 lenses |
| Comfilcon A | Corneal Coverage | Not Covering | 0 lenses |
| Lotrafilcon B | Corneal Coverage | Normal Coverage | 114 lenses |
| Lotrafilcon B | Corneal Coverage | Not Covering | 0 lenses |
Secondary
Likelihood of Switching From Habitual Lens to Study Lens
Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Likelihood of Switching From Habitual Lens to Study Lens | very likely | 10 participants |
| Comfilcon A | Likelihood of Switching From Habitual Lens to Study Lens | likely | 22 participants |
| Comfilcon A | Likelihood of Switching From Habitual Lens to Study Lens | unlikely | 13 participants |
| Comfilcon A | Likelihood of Switching From Habitual Lens to Study Lens | very unlikely | 11 participants |
| Lotrafilcon B | Likelihood of Switching From Habitual Lens to Study Lens | very unlikely | 23 participants |
| Lotrafilcon B | Likelihood of Switching From Habitual Lens to Study Lens | very likely | 9 participants |
| Lotrafilcon B | Likelihood of Switching From Habitual Lens to Study Lens | unlikely | 16 participants |
| Lotrafilcon B | Likelihood of Switching From Habitual Lens to Study Lens | likely | 9 participants |
Secondary
Likelihood to Continue Wearing the Study Lens
Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Likelihood to Continue Wearing the Study Lens | Very Likely | 13 participants |
| Comfilcon A | Likelihood to Continue Wearing the Study Lens | Likely | 23 participants |
| Comfilcon A | Likelihood to Continue Wearing the Study Lens | Unlikely | 10 participants |
| Comfilcon A | Likelihood to Continue Wearing the Study Lens | Very Unlikely | 10 participants |
| Lotrafilcon B | Likelihood to Continue Wearing the Study Lens | Very Unlikely | 19 participants |
| Lotrafilcon B | Likelihood to Continue Wearing the Study Lens | Very Likely | 6 participants |
| Lotrafilcon B | Likelihood to Continue Wearing the Study Lens | Unlikely | 19 participants |
| Lotrafilcon B | Likelihood to Continue Wearing the Study Lens | Likely | 13 participants |
Secondary
Overall Fit Acceptance
Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Fit Acceptance | 3.74 units on a scale | Standard Deviation 0.48 |
| Lotrafilcon B | Overall Fit Acceptance | 3.68 units on a scale | Standard Deviation 0.47 |
Secondary
Overall Fit Acceptance
Assessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Fit Acceptance | Grade 0 | 0 lenses |
| Comfilcon A | Overall Fit Acceptance | Grade 3 | 22 lenses |
| Comfilcon A | Overall Fit Acceptance | Grade 2 | 0 lenses |
| Comfilcon A | Overall Fit Acceptance | Grade 4 | 94 lenses |
| Comfilcon A | Overall Fit Acceptance | Grade 1 | 0 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 4 | 71 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 0 | 0 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 2 | 0 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 3 | 41 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 1 | 2 lenses |
Secondary
Overall Fit Acceptance
Assessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Time frame: 4 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Fit Acceptance | Grade 4 | 87 lenses |
| Comfilcon A | Overall Fit Acceptance | Grade 1 | 0 lenses |
| Comfilcon A | Overall Fit Acceptance | Grade 0 | 0 lenses |
| Comfilcon A | Overall Fit Acceptance | Grade 2 | 6 lenses |
| Comfilcon A | Overall Fit Acceptance | Grade 3 | 17 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 2 | 4 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 3 | 36 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 4 | 72 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 0 | 0 lenses |
| Lotrafilcon B | Overall Fit Acceptance | Grade 1 | 0 lenses |
Secondary
Participant Likelihood of Recommendation of a Study Lens
Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Participant Likelihood of Recommendation of a Study Lens | Very Unlikely | 6 participants |
| Comfilcon A | Participant Likelihood of Recommendation of a Study Lens | Unlikely | 6 participants |
| Comfilcon A | Participant Likelihood of Recommendation of a Study Lens | Likely | 19 participants |
| Comfilcon A | Participant Likelihood of Recommendation of a Study Lens | Very Likely | 22 participants |
| Lotrafilcon B | Participant Likelihood of Recommendation of a Study Lens | Very Likely | 14 participants |
| Lotrafilcon B | Participant Likelihood of Recommendation of a Study Lens | Very Unlikely | 12 participants |
| Lotrafilcon B | Participant Likelihood of Recommendation of a Study Lens | Likely | 16 participants |
| Lotrafilcon B | Participant Likelihood of Recommendation of a Study Lens | Unlikely | 11 participants |
Secondary
Participant Recommendation of a Study Lens
Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comfilcon A | Participant Recommendation of a Study Lens | 31 participants |
| Lotrafilcon B | Participant Recommendation of a Study Lens | 22 participants |
Secondary
Post Blink Movement
Assessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time frame: Dispense
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Post Blink Movement | Movement Grade 1 | 11 lenses |
| Comfilcon A | Post Blink Movement | Movement Grade 3 | 11 lenses |
| Comfilcon A | Post Blink Movement | Movement Grade 2 | 104 lenses |
| Comfilcon A | Post Blink Movement | Movement Grade 4 | 0 lenses |
| Comfilcon A | Post Blink Movement | Movement Grade 0 | 0 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 4 | 0 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 0 | 0 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 1 | 13 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 2 | 92 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 3 | 15 lenses |
Secondary
Post Blink Movement
Assessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Post Blink Movement | Movement Grade 1 | 9 lenses |
| Comfilcon A | Post Blink Movement | Movement Grade 0 | 0 lenses |
| Comfilcon A | Post Blink Movement | Movement Grade 2 | 107 lenses |
| Comfilcon A | Post Blink Movement | Movement Grade 4 | 0 lenses |
| Comfilcon A | Post Blink Movement | Movement Grade 3 | 0 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 4 | 1 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 3 | 12 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 0 | 0 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 1 | 18 lenses |
| Lotrafilcon B | Post Blink Movement | Movement Grade 2 | 83 lenses |
Secondary
Post Blink Movement
Assessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time frame: 4 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Post Blink Movement | Movement Grade 0 | 0 units on a scale |
| Comfilcon A | Post Blink Movement | Movement Grade 1 | 8 units on a scale |
| Comfilcon A | Post Blink Movement | Movement Grade 2 | 96 units on a scale |
| Comfilcon A | Post Blink Movement | Movement Grade 3 | 6 units on a scale |
| Comfilcon A | Post Blink Movement | Movement Grade 4 | 0 units on a scale |
| Lotrafilcon B | Post Blink Movement | Movement Grade 4 | 2 units on a scale |
| Lotrafilcon B | Post Blink Movement | Movement Grade 3 | 9 units on a scale |
| Lotrafilcon B | Post Blink Movement | Movement Grade 1 | 11 units on a scale |
| Lotrafilcon B | Post Blink Movement | Movement Grade 0 | 0 units on a scale |
| Lotrafilcon B | Post Blink Movement | Movement Grade 2 | 92 units on a scale |
Secondary
Push Up Test
Assessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Time frame: 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Push Up Test | 51.73 units on a scale | Standard Deviation 10.8 |
| Lotrafilcon B | Push Up Test | 52.24 units on a scale | Standard Deviation 10.46 |
Secondary
Push Up Test
Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Push Up Test | 49.25 units on a scale | Standard Deviation 11.42 |
| Lotrafilcon B | Push Up Test | 48.13 units on a scale | Standard Deviation 11.34 |
Secondary
Push Up Test
Assessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Push Up Test | 50.78 units on a scale | Standard Deviation 10.71 |
| Lotrafilcon B | Push Up Test | 51.9 units on a scale | Standard Deviation 11.66 |
Secondary
Rewetting Drops
Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Rewetting Drops | Uses | 50 participants |
| Comfilcon A | Rewetting Drops | Does Not Use | 8 participants |
| Lotrafilcon B | Rewetting Drops | Uses | 47 participants |
| Lotrafilcon B | Rewetting Drops | Does Not Use | 10 participants |
Secondary
Surface Deposition
Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Surface Deposition | 0.37 units on a scale | Standard Deviation 1.46 |
| Lotrafilcon B | Surface Deposition | 0.23 units on a scale | Standard Deviation 1.1 |
Secondary
Surface Deposition
Assessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)
Time frame: 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Surface Deposition | 0.58 units on a scale | Standard Deviation 1.18 |
| Lotrafilcon B | Surface Deposition | 1.04 units on a scale | Standard Deviation 1.65 |
Secondary
Surface Deposition
Assessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Surface Deposition | 0.46 units on a scale | Standard Deviation 0.85 |
| Lotrafilcon B | Surface Deposition | 1.05 units on a scale | Standard Deviation 1.62 |
Secondary
Surface Wetting
Assessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= \> 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Surface Wetting | 7.23 units on a scale | Standard Deviation 1.83 |
| Lotrafilcon B | Surface Wetting | 7.05 units on a scale | Standard Deviation 1.61 |
Secondary
Surface Wetting
Assessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= \> 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Time frame: 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Surface Wetting | 7.09 units on a scale | Standard Deviation 1.84 |
| Lotrafilcon B | Surface Wetting | 6.95 units on a scale | Standard Deviation 1.53 |
Secondary
Surface Wetting
Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= \> 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Surface Wetting | 7.59 units on a scale | Standard Deviation 1.45 |
| Lotrafilcon B | Surface Wetting | 7.75 units on a scale | Standard Deviation 1.09 |
Other Pre-specified
The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.
The number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, \>3)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses. | 2.06 number of trial lenses | Standard Deviation 0.3 |
| Lotrafilcon B | The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses. | 2.03 number of trial lenses | Standard Deviation 0.18 |