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The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A toric | Experimental | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A Toric | Device | Contact lenses |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever. | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
| Overall Vision | Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time. | 2 weeks prior to baseline, Baseline, 2 weeks post |
| Handling | Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
| Overall Satisfaction | Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied. | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
| Lens Fit - Rotation | Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation. | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
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Inclusion Criteria:
Has had an oculo-visual examination in the last two years
Is at least 18 years of age and has full legal capacity to volunteer
Has read and understood the information consent letter
Is willing and able to follow instructions and maintain the appointment schedule
Is correctable to a visual acuity of 20/50 or better (in at least one eye)
Currently wears soft toric contact lenses in both eyes
Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:
Has clear corneas and no active ocular disease
Demonstrates an acceptable fit with the study lenses
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Bergmanson, OD PhD | Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston | Principal Investigator |
| Pete Kollbaum, OD PhD | Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant discontinued and therefore data was not included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline Characteristics | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
| 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 | Overall Comfort | Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever. | One participant discontinued and therefore data was not included in analysis. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
|
From dispense up to two weeks for each study lenses
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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 Toric XR MTO | Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses. comfilcon A Toric XR (MTO) contact lenses |
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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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| Lens Fit - Overall Stability | Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
| Lens Fit Acceptance | General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum) | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
| Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe | Baseline and 2 weeks |
| Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection | Baseline and 2 weeks |
| Anterior Ocular Health - Corneal Staining | Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area | Baseline and 2 weeks |
| Anterior Ocular Health - Conjunctival Staining and Indentation | Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe | Baseline and 2 weeks |
| Visual Acuity | Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR. | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
| Subjective Preference - Comfort | Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Baseline and 2 weeks |
| Preference - Vision | Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Baseline and 2 weeks |
| Preference - Handling | Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Baseline and 2 weeks |
| Overall Preference | Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Baseline and 2 weeks |
| Investigator Acceptability | Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree. | Baseline and 2 weeks |
| Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston | Houston | Texas | 77204 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Comfilcon A - 2 Weeks | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
|
|
| Primary | Overall Vision | Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time. | One participant discontinued and therefore data was not included in analysis. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks prior to baseline, Baseline, 2 weeks post |
|
|
|
| Primary | Handling | Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy | One participant discontinued and therefore data was not included in analysis. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
|
|
|
| Primary | Overall Satisfaction | Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied. | One participant discontinued and therefore data was not included in analysis. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
|
|
|
| Primary | Lens Fit - Rotation | Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation. | One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses. | Posted | Number | percentage of eyes | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | eyes | eyes |
|
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|
| Primary | Lens Fit - Overall Stability | Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability | One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | eyes | eyes |
|
|
|
| Primary | Lens Fit Acceptance | General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum) | One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | eyes | eyes |
|
|
|
| Primary | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks | eyes | eyes |
|
|
|
| Primary | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks | eyes | eyes |
|
|
|
| Primary | Anterior Ocular Health - Corneal Staining | Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks | eyes | eyes |
|
|
|
| Primary | Anterior Ocular Health - Conjunctival Staining and Indentation | Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks | eyes | eyes |
|
|
|
| Primary | Visual Acuity | Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR. | One participant discontinued and therefore data was not included in analysis. | Posted | Mean | Standard Deviation | LogMAR | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
|
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| Primary | Subjective Preference - Comfort | Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Posted | Number | percentage of subjects | Baseline and 2 weeks |
|
|
|
| Primary | Preference - Vision | Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Posted | Number | percentage of subjects | Baseline and 2 weeks |
|
|
|
| Primary | Preference - Handling | Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Missing data for handling preference for one participant. | Posted | Number | percentage of subjects | Baseline and 2 weeks |
|
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| Primary | Overall Preference | Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Posted | Number | percentage of subjects | Baseline and 2 weeks |
|
|
|
| Primary | Investigator Acceptability | Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree. | Posted | Number | percentage of subjects | Baseline and 2 weeks |
|
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| 0 |
| 15 |
| 0 |
| 15 |
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.
| Title | Measurements |
|---|---|
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| <=10 degrees |
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| <=15 degrees |
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| >15 degrees |
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| Palpebral Conjunctival Papillae (Superior) |
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| Palpebral Conjunctival Papillae (Inferior) |
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| Bulbar (superior) |
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| Bulbar (inferior) |
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| Limbal (nasal) |
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| Limbal (temporal) |
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| Limbal (superior) |
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| Limbal (inferior) |
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| Temporal |
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| Superior |
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| Inferior |
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| Temporal |
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| Superior |
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| Inferior |
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| High Contrast Low Illumination (monocular) |
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| High Contrast Low Illumination (binocular) |
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| Habitual lenses |
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| Habitual lenses |
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| Habitual lenses |
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| Missing |
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| Habitual lenses |
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| Disagree |
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