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The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.
This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:
Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D
Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D
Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D
Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| filcon IV I (BC 8.6) / ocufilcon D (pair one) | Experimental | Participants were randomized to a test and control lens for each pair in a contralateral design. |
|
| filcon IV I (BC 8.7) / ocufilcon D (pair two) | Experimental | Participants were randomized to a test and control lens for each pair in a contralateral design. |
|
| methafilcon A (BC 8.6) / ocufilcon D (pair three) | Experimental | Participants were randomized to a test and control lens for each pair in a contralateral design. |
|
| methafilcon A (BC 8.7) / somofilcon A (pair four) | Experimental | Participants were randomized to a test and control lens for each pair in a contralateral design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filcon IV I (BC 8.6) | Device | control lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Centration - Pair One | Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Baseline and 1 hour |
| Centration - Pair Two | Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Baseline and 1 hour |
| Centration - Pair Three | Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Baseline and 1 hour |
| Centration - Pair Four | Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Baseline and 1 hour |
| Post-blink Movement - Pair One | Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Baseline |
| Post-blink Movement - Pair One | Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | 1 hour |
| Post-blink Movement - Pair Two |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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 CL prescription outside the range of - 1.00 to - 6.00D
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities.
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic, National Autonomous University | Mexico City | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Centration - Pair One | Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Posted | Number | number of eyes | Baseline and 1 hour |
|
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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 | Overall Participants | Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Global Medical Scientific Affairs | CooperVision Inc. | 925 621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| filcon IV I (BC 8.7) |
| Device |
control lens |
|
| ocufilcon D | Device | test lens |
|
| methafilcon A (BC 8.6) | Device | control lens |
|
| methafilcon A (BC 8.7) | Device | control lens |
|
| somofilcon A | Device | test lens |
|
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
| Baseline |
| Post-blink Movement - Pair Two | Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | 1 hour |
| Post-blink Movement - Pair Three | Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Baseline |
| Post-blink Movement - Pair Three | Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | 1 hour |
| Post-blink Movement - Pair Four | Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Baseline |
| Post-blink Movement - Pair Four | Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | 1 hour |
| Lens Tightness - Pair One | Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Baseline and 1 hour |
| Lens Tightness - Pair Two | Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Baseline and 1 hour |
| Lens Tightness - Pair Three | Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Baseline and 1 hour |
| Lens Tightness - Pair Four | Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Baseline and 1 hour |
| Overall Fit Preference - Pair One | Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference. | Baseline and 1 hour |
| Overall Fit Acceptance - Pair Two | Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference. | Baseline and 1 hour |
| Overall Fit Acceptance - Pair Three | Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference. | Baseline and 1 hour |
| Overall Fit Acceptance - Pair Four | Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference. | Baseline and 1 hour |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Centration - Pair Two | Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Posted | Number | number of eyes | Baseline and 1 hour |
|
|
|
| Primary | Centration - Pair Three | Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Posted | Number | number of eyes | Baseline and 1 hour |
|
|
|
| Primary | Centration - Pair Four | Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Posted | Number | number of eyes | Baseline and 1 hour |
|
|
|
| Primary | Post-blink Movement - Pair One | Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | number of eyes | Baseline |
|
|
|
| Primary | Post-blink Movement - Pair One | Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | number of eyes | 1 hour |
|
|
|
| Primary | Post-blink Movement - Pair Two | Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | number of eyes | Baseline |
|
|
|
| Primary | Post-blink Movement - Pair Two | Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | number of eyes | 1 hour |
|
|
|
| Primary | Post-blink Movement - Pair Three | Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | number of eyes | Baseline |
|
|
|
| Primary | Post-blink Movement - Pair Three | Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | number of eyes | 1 hour |
|
|
|
| Primary | Post-blink Movement - Pair Four | Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | number of eyes | Baseline |
|
|
|
| Primary | Post-blink Movement - Pair Four | Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | number of eyes | 1 hour |
|
|
|
| Primary | Lens Tightness - Pair One | Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Posted | Mean | Standard Deviation | Percent lens tightness | Baseline and 1 hour |
|
|
|
| Primary | Lens Tightness - Pair Two | Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Posted | Mean | Standard Deviation | percent lens tightness | Baseline and 1 hour |
|
|
|
| Primary | Lens Tightness - Pair Three | Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Posted | Mean | Standard Deviation | percent lens tightness | Baseline and 1 hour |
|
|
|
| Primary | Lens Tightness - Pair Four | Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Posted | Mean | Standard Deviation | percent lens tightness | Baseline and 1 hour |
|
|
|
| Primary | Overall Fit Preference - Pair One | Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference. | Posted | Number | number of subjects | Baseline and 1 hour |
|
|
|
| Primary | Overall Fit Acceptance - Pair Two | Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference. | Posted | Number | number of subjects | Baseline and 1 hour |
|
|
|
| Primary | Overall Fit Acceptance - Pair Three | Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference. | Posted | Number | number of subjects | Baseline and 1 hour |
|
|
|
| Primary | Overall Fit Acceptance - Pair Four | Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference. | Posted | Number | number of subjects | Baseline and 1 hour |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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| Baseline - Decentration unacceptable |
|
| 1 hour - Optimum |
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| 1 hour - Decentration acceptable |
|
| 1 hour - Decentration unacceptable |
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| Baseline - Decentration unacceptable |
|
| 1 hour - Optimum |
|
| 1 hour - Decentration acceptable |
|
| 1 hour - Decentration unacceptable |
|
| Baseline - Decentration unacceptable |
|
| 1 hour - Optimum |
|
| 1 hour - Decentration acceptable |
|
| 1 hour - Decentration unacceptable |
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| Optimum |
|
| Moderate |
|
| Excessive |
|
| Optimum |
|
| Moderate |
|
| Excessive |
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| Optimum |
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| Moderate |
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| Excessive |
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| Optimum |
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| Moderate |
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| Excessive |
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| Optimum |
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| Moderate |
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| Excessive |
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| Optimum |
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| Moderate |
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| Excessive |
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| Optimum |
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| Moderate |
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| Excessive |
|
| Optimum |
|
| Moderate |
|
| Excessive |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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