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A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A | Active Comparator | Daily wear soft contact lens comfilcon A |
|
| lotrafilcon B | Active Comparator | Daily wear soft contact lens lotrafilcon B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Dispense |
| 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) | Dispense |
| Average Daily Wearing Time | Participants measure of average daily wear time for study lenses at 2 Weeks. | 2 weeks |
| 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) | 2 weeks |
| Comfort | Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel). | 2 weeks |
| Dryness | Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness). | 2 weeks |
| Handling | Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Dispense |
| Surface Wetting |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Dispense |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Siegel, OD | CooperVision, US | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Eye Care Center | Campbell | California | 95008 | United States | ||
| Golden Optometric Group |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A Then Lotrafilcon B | Each subject randomized to wear either 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. |
| FG001 | Lotrafilcon B Then Comfilcon A | Each subject randomized to wear either 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Lotrafilcon B Then Comfilcon A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Dispense |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comfilcon A | Daily wear soft contact lens comfilcon A 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Corneal Ulcer | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald Siegel, OD Principal Investigator | CooperVision | (949) 597-4700 | dsiegel@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| lotrafilcon B | Device | 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. |
|
| Vision Satisfaction |
Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied) |
| 2 weeks |
| 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) | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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 | 2 weeks |
| 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 | 2 weeks |
| 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 | 2 weeks |
| 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 | 2 weeks |
| 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 | 2 weeks |
| 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) | 2 weeks |
| 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 ) | 2 weeks |
| 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) | 4 weeks |
| Average Daily Wearing Time | Participants measure of average daily wear time for study lenses at 4 weeks. | 4 weeks |
| 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). | 4 weeks |
| Comfort | Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel). | 4 weeks |
| Dryness | Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness). | 4 weeks |
| Handling | Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy). | 4 weeks |
| 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) | 4 weeks |
| 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) | 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| 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 | 4 weeks |
| 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 | 4 weeks |
| 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 | 4 weeks |
| 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 | 4 weeks |
| 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 | 4 weeks |
| 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). | 4 weeks |
| 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). | 4 weeks |
| Lens Preference for Handling | Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual). | 4 weeks |
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) |
| Dispense |
| 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) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| Rewetting Drops | Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops). | 2 weeks |
| 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 | 2 Weeks |
| 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) | 2 Weeks |
| 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) | 2 Weeks |
| Centration | Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal | 2 Weeks |
| 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) | 2 Weeks |
| 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) | 2 Weeks |
| 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) | 2 Weeks |
| 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) | 2 Weeks |
| 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 | 4 Weeks |
| 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) | 4 Weeks |
| 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) | 4 Weeks |
| 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) | 4 Weeks |
| Corneal Coverage | Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering) | 4 Weeks |
| 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) | 4 Weeks |
| 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) | 4 Weeks |
| 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) | 4 Weeks |
| 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 | 4 weeks |
| 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 | 4 weeks |
| 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). | 4 weeks |
| 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). | 4 weeks |
| Whittier |
| California |
| 90606 |
| United States |
| Drs. Quinn, Foster, &Associates | Athens | Georgia | 45701 | United States |
| Davis EyeCare Associates | Oak Lawn | Illinois | 60453 | United States |
| Kannarr Eye Care LLC | Pittsburg | Kansas | 66762 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Adverse Event |
|
| Protocol Violation |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | Dispense |
|
|
|
| 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 | Posted | Mean | Standard Deviation | logMAR | Dispense |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | Dispense | eyes | eyes |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | Dispense | eyes | eyes |
|
|
|
| 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) | Posted | Number | lenses | Dispense | lenses | 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) | Posted | Number | lenses | Dispense | lenses | lenses |
|
|
|
| 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) | Posted | Number | lenses | Dispense | lenses | lenses |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | Dispense | lenses | lenses |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | Dispense | lenses | lenses |
|
|
|
| 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) | Posted | Mean | Standard Deviation | number of trial lenses | Dispense | lenses | lenses |
|
|
|
| Primary | Average Daily Wearing Time | Participants measure of average daily wear time for study lenses at 2 Weeks. | Posted | Mean | Standard Deviation | hours | 2 weeks |
|
|
|
| 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). | Posted | Number | participants | 2 weeks |
|
|
|
| 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) | Posted | Mean | Standard Deviation | hours | 2 weeks |
|
|
|
| Primary | Comfort | Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Dryness | Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Handling | Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Vision Satisfaction | Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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. | Posted | Number | participants | 2 weeks |
|
|
|
| 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. | Posted | Number | participants | 2 weeks |
|
|
|
| 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 | Posted | Number | participants | 2 weeks |
|
|
|
| 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 | Posted | Number | participants | 2 weeks |
|
|
|
| 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 | Posted | Number | participants | 2 weeks |
|
|
|
| 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 | Posted | Number | participants | 2 weeks |
|
|
|
| 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 | Posted | Number | participants | 2 weeks |
|
|
|
| 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) | Posted | Number | participants | 2 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | logMAR | 2 Weeks |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks | eyes | eyes |
|
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| Secondary | Centration | Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal | Posted | Number | lenses | 2 Weeks | lenses | lenses |
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| 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) | Posted | Number | lenses | 2 Weeks | lenses | lenses |
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| 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) | Posted | Number | lenses | 2 Weeks | lenses | lenses |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks | lenses | lenses |
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| 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) | Posted | Number | lenses | 2 Weeks | lenses | lenses |
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| 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 ) | Posted | Number | participants | 2 weeks |
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| 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) | Posted | Mean | Standard Deviation | hours | 4 weeks |
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| Primary | Average Daily Wearing Time | Participants measure of average daily wear time for study lenses at 4 weeks. | Posted | Mean | Standard Deviation | hours | 4 weeks |
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| 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). | Posted | Number | participants | 4 weeks |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | Handling | Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 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. | Posted | Number | participants | 4 weeks |
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| 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. | Posted | Number | participants | 4 weeks |
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| 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 | Posted | Number | participants | 4 weeks |
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| 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 | Posted | Number | participants | 4 weeks |
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| 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 | Posted | Number | participants | 4 weeks |
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| 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 | Posted | Number | participants | 4 weeks |
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| 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 | Posted | Mean | Standard Deviation | logMAR | 4 Weeks |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 4 Weeks |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 4 Weeks |
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| 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) | Posted | Number | lenses | 4 Weeks | lenses | lenses |
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| Secondary | Corneal Coverage | Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering) | Posted | Number | lenses | 4 Weeks | lenses | lenses |
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| 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) | Posted | Number | units on a scale | 4 Weeks | lenses | lenses |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 4 Weeks | lenses | lenses |
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| 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) | Posted | Number | lenses | 4 Weeks | lenses | lenses |
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| 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 | Posted | Number | participants | 4 weeks |
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| 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 | Posted | Number | participants | 4 weeks |
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| 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 | Posted | Number | participants | 4 weeks |
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| 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). | Posted | Number | participants | 4 weeks |
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| 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). | Posted | Number | participants | 4 weeks |
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| 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). | Posted | Number | participants | 4 weeks |
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| 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). | Posted | Number | participants | 4 weeks |
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| Primary | Lens Preference for Handling | Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual). | Posted | Number | participants | 4 weeks |
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| 1 |
| 63 |
| 0 |
| 63 |
| EG001 | Lotrafilcon B | Daily wear soft contact lens lotrafilcon B 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. | 0 | 63 | 0 | 63 |
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
| Movement Grade 2 |
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| Movement Grade 3 |
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| Movement Grade 4 |
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| Prior to Removal |
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| Overall |
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| Overall |
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| Average |
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| Fair |
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| Poor |
|
| Average |
|
| Fair |
|
| Poor |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Handling |
|
| Vision |
|
| Overall |
|
| Movement Grade 2 |
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| Movement Grade 3 |
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| Movement Grade 4 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Handling |
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| Vision |
|
| Overall |
|
| Prior to Removal |
|
| Overall |
|
| Overall |
|
| Average |
|
| Fair |
|
| Poor |
|
| Average |
|
| Fair |
|
| Poor |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Movement Grade 2 |
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| Movement Grade 3 |
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| Movement Grade 4 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| unlikely |
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| very unlikely |
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| Unlikely |
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| Very Unlikely |
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| Somewhat Dissatisfied |
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| Completely Dissatisfied |
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| Likely |
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| Very Likely |
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| Handling |
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| Vision |
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| Overall |
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| Title | Measurements |
|---|---|
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| Vision |
|
| Overall |
|