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The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.
Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A MTO | Experimental | Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. |
|
| comfilcon A | Active Comparator | Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A MTO | Device | Randomized to a test lens in one eye and control lens in the other as a matched pair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Surface Assessment of Study Lenses - Surface Wettability | Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent) | 15min & 6hrs |
| Lens Surface Assessment of Study Lenses - Deposits | Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface) | 15min & 6hrs |
| Lens Surface Assessment of Study Lenses - Surface Acceptance | Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent) | 15min & 6hrs |
| Subjective Rating For Comfort - Comfort Since Last Visit | Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever) | 15min, 3hrs, 6hrs |
| Subjective Rating For Comfort Preference | Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens) | 1min, 15min, 3hrs, 6hrs |
| Subjective Rating For Handling - Insertion | Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye) | 1 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pete S Kollbaum, O.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CORL, Indiana University | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric | Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric | Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Lens Surface Assessment of Study Lenses - Surface Wettability | Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent) | Posted | Mean | Standard Deviation | units on a scale | 15min & 6hrs |
|
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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 MTO | Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager, Clinical Research | CooperVision, Inc | 9257306754 | pchamberlain@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| comfilcon A | Device | Randomized to a test lens in one eye and control lens in the other as a matched pair. |
|
|
| Subjective Rating For Handling - Removal |
Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye) |
| 1 min |
| Investigator's Assessment of Stability | Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability. | 15min & 6hrs |
| General Lens Fit - Fit Acceptance | Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect) | 15min & 6hrs |
| Lens Fitting - Rotation/Mislocation | Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-). | Baseline, 15min & 6hrs |
| Anterior Ocular Health - Corneal Staining (Central) | Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs |
| Anterior Ocular Health - Corneal Staining (Nasal) | Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs |
| Anterior Ocular Health - Corneal Staining (Temporal) | Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs |
| Anterior Ocular Health - CornealStaining (Superior) | Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs |
| Anterior Ocular Health - Corneal Staining (Inferior) | Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs |
| Anterior Ocular Health - Conjunctival Staining (Nasal) | Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | baseline & 6hrs |
| Anterior Ocular Health - Conjunctival Staining (Superior) | Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | baseline & 6hrs |
| Anterior Ocular Health - Conjunctival Staining (Temporal) | Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | baseline & 6hrs |
| Anterior Ocular Health - Conjunctival Staining (Inferior) | Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | baseline & 6hrs |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Primary | Lens Surface Assessment of Study Lenses - Deposits | Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface) | Posted | Mean | Standard Deviation | units on a scale | 15min & 6hrs |
|
|
|
| Primary | Lens Surface Assessment of Study Lenses - Surface Acceptance | Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent) | Posted | Mean | Standard Deviation | units on a scale | 15min & 6hrs |
|
|
|
| Primary | Subjective Rating For Comfort - Comfort Since Last Visit | Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever) | Posted | Mean | Standard Deviation | units on a scale | 15min, 3hrs, 6hrs |
|
|
|
| Primary | Subjective Rating For Comfort Preference | Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens) | Posted | Number | percentage of subjects | 1min, 15min, 3hrs, 6hrs |
|
|
|
| Primary | Subjective Rating For Handling - Insertion | Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye) | Posted | Mean | Standard Deviation | units on a scale | 1 min |
|
|
|
| Primary | Subjective Rating For Handling - Removal | Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye) | Posted | Mean | Standard Deviation | units on a scale | 1 min |
|
|
|
| Primary | Investigator's Assessment of Stability | Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability. | Posted | Mean | Standard Deviation | degrees | 15min & 6hrs |
|
|
|
| Primary | General Lens Fit - Fit Acceptance | Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect) | Posted | Mean | Standard Deviation | units on a scale | 15min & 6hrs |
|
|
|
| Primary | Lens Fitting - Rotation/Mislocation | Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-). | Posted | Mean | Standard Deviation | degrees | Baseline, 15min & 6hrs |
|
|
|
| Primary | Anterior Ocular Health - Corneal Staining (Central) | Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
|
|
| Primary | Anterior Ocular Health - Corneal Staining (Nasal) | Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
|
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| Primary | Anterior Ocular Health - Corneal Staining (Temporal) | Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
|
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| Primary | Anterior Ocular Health - CornealStaining (Superior) | Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
|
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| Primary | Anterior Ocular Health - Corneal Staining (Inferior) | Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
|
|
| Primary | Anterior Ocular Health - Conjunctival Staining (Nasal) | Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
|
|
| Primary | Anterior Ocular Health - Conjunctival Staining (Superior) | Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
|
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| Primary | Anterior Ocular Health - Conjunctival Staining (Temporal) | Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
|
|
| Primary | Anterior Ocular Health - Conjunctival Staining (Inferior) | Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | Posted | Mean | Standard Deviation | units on a scale | baseline & 6hrs |
|
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| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Comfilcon A | Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A MTO: Randomized to a test lens in one eye and control lens in the other as a matched pair. | 0 | 30 | 0 | 30 |
Principal Investigators are NOT employed by the organization sponsoring the study.
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
| 6 hours |
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| Title | Measurements |
|---|---|
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| 3 hours |
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| 6 hours |
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| 6 hours |
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