MyopiaNCT01952665
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
A study testing comfilcon A and lotrafilcon B in people with Myopia, run by CooperVision, Inc. at 6 sites in United States.
Trial summary
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- comfilcon A and lotrafilcon B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Drs. Quinn, Foster, &Associates
Athens, Georgia, 45701
Family Eye Care Center
Campbell, California, 95008
Complete Eye Care of Medina
Medina, Minnesota, 55340
Davis EyeCare Associates
Oak Lawn, Illinois, 60453
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762
Golden Optometric Group
Whittier, California, 90606
About this study
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Read the detailed description
Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.
- Conditions
- Myopia
- Being tested
- comfilcon A, lotrafilcon B
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comfilcon ADevice
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.
lotrafilcon BDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| comfilcon A | Active comparator | Daily wear soft contact lens comfilcon A Receives: Device: lotrafilcon B |
| lotrafilcon B | Active comparator | Daily wear soft contact lens lotrafilcon B Receives: Device: comfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Dispense
Average Daily Wearing Time
Participants measure of average daily wear time for study lenses at 2 Weeks.
Measured: 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)
Measured: 2 weeks
Comfort
Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Measured: 2 weeks
Dryness
Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).
Measured: 2 weeks
Handling
Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).
Measured: 2 weeks
Vision Satisfaction
Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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 )
Measured: 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)
Measured: 4 weeks
Average Daily Wearing Time
Participants measure of average daily wear time for study lenses at 4 weeks.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 4 weeks
Handling
Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 4 weeks
Lens Preference for Handling
Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Measured: 4 weeks
Secondary outcomes (29)
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
Measured: Dispense
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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)
Measured: 2 Weeks
Centration
Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4 Weeks
Corneal Coverage
Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Siegel, OD, Principal investigator, CooperVision, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952665
- Sponsor's protocol ID
- EX-MKTG-41
- Status last verified
- May 2017
- First submitted
- 18 Sep 2013
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
- ClinicalTrials.gov ID
- NCT01952665
- Acronym / sponsor ID
- EX-MKTG-41
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 24 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comfilcon A | Active comparator | Device: lotrafilcon BDaily wear soft contact lens comfilcon A |
| lotrafilcon B | Active comparator | Device: comfilcon ADaily wear soft contact lens lotrafilcon B |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comfilcon AEach 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. | Device | lotrafilcon B |
| lotrafilcon BEach 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. | Device | comfilcon A |
Primary outcome
Comfort at Insertion
Time frame: 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
Time frame: 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
Time frame: 2 weeks
Participants measure of average daily wear time for study lenses at 2 Weeks.
Comfortable Wearing Time
Time frame: 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
Time frame: 2 weeks
Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Dryness
Time frame: 2 weeks
Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).
Handling
Time frame: 2 weeks
Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).
Vision Satisfaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 )
Comfortable Wearing Time
Time frame: 4 weeks
Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)
Average Daily Wearing Time
Time frame: 4 weeks
Participants measure of average daily wear time for study lenses at 4 weeks.
Rewetting Drops
Time frame: 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).
Comfort
Time frame: 4 weeks
Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Dryness
Time frame: 4 weeks
Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).
Handling
Time frame: 4 weeks
Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).
Vision Satisfaction
Time frame: 4 weeks
Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Eye Whiteness/Redness
Time frame: 4 weeks
Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)
Overall Sensation of Moistness
Time frame: 4 weeks
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.
Overall Sensation of Smoothness
Time frame: 4 weeks
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.
Overall Comfort Satisfaction
Time frame: 4 weeks
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
Overall Dryness Satisfaction
Time frame: 4 weeks
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
Overall Handling Satisfaction
Time frame: 4 weeks
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
Overall Vision Satisfaction
Time frame: 4 weeks
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
Overall Satisfaction
Time frame: 4 weeks
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
Lens Preference
Time frame: 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.
Time frame: 4 weeks
Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Lens Preference for Handling
Time frame: 4 weeks
Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
29 secondary outcomes
Binocular Visual Acuity logMAR
Time frame: Dispense
Surface Wetting
Time frame: Dispense
Surface Deposition
Time frame: Dispense
Centration
Time frame: Dispense
Corneal Coverage
Time frame: Dispense
Post Blink Movement
Time frame: Dispense
Push Up Test
Time frame: Dispense
Overall Fit Acceptance
Time frame: Dispense
Rewetting Drops
Time frame: 2 weeks
Binocular Visual Acuity logMAR
Time frame: 2 Weeks
Surface Wetting
Time frame: 2 Weeks
Surface Deposition
Time frame: 2 Weeks
Centration
Time frame: 2 Weeks
Corneal Coverage
Time frame: 2 Weeks
Post Blink Movement
Time frame: 2 Weeks
Push Up Test
Time frame: 2 Weeks
Overall Fit Acceptance
Time frame: 2 Weeks
Binocular Visual Acuity logMAR
Time frame: 4 Weeks
Surface Wetting
Time frame: 4 Weeks
Surface Deposition
Time frame: 4 Weeks
Centration
Time frame: 4 Weeks
Corneal Coverage
Time frame: 4 Weeks
Post Blink Movement
Time frame: 4 Weeks
Push Up Test
Time frame: 4 Weeks
Overall Fit Acceptance
Time frame: 4 Weeks
Likelihood of Switching From Habitual Lens to Study Lens
Time frame: 4 weeks
Likelihood to Continue Wearing the Study Lens
Time frame: 4 weeks
Participant Recommendation of a Study Lens
Time frame: 4 weeks
Participant Likelihood of Recommendation of a Study Lens
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Siegel, OD principal investigator
CooperVision, US
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comfilcon A and lotrafilcon B in people with Myopia, run by CooperVision, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort at Insertion (time frame: Dispense). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.