Astigmatism, Myopia
Conditions
Brief summary
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.
Detailed description
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.
Interventions
DEVICEcomfilcon A Toric
Contact lenses
Sponsors
CooperVision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25 * +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25 * -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75 * -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75 * +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75 * Has clear corneas and no active ocular disease * Demonstrates an acceptable fit with the study lenses
Exclusion criteria
* Has never worn contact lenses before; * Has any systemic disease affecting ocular health; * Is using any systemic or topical medications that will affect ocular health; * Has any ocular pathology or abnormality that would affect the wearing of contact lenses; * Has undergone corneal refractive surgery; * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit - Rotation | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 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. |
| Overall Comfort | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 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. |
| Overall Vision | 2 weeks prior to baseline, Baseline, 2 weeks post | 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. |
| Handling | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 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 |
| Overall Satisfaction | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 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. |
| Lens Fit - Overall Stability | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 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 |
| Lens Fit Acceptance | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 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) |
| Anterior Ocular Health - Palpebral Hyperemia and Roughness | Baseline and 2 weeks | Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe |
| Anterior Ocular Health - Bulbar and Limbal Redness | Baseline and 2 weeks | Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection |
| Anterior Ocular Health - Corneal Staining | Baseline and 2 weeks | Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= \>45% of area |
| Anterior Ocular Health - Conjunctival Staining and Indentation | Baseline and 2 weeks | Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe |
| Visual Acuity | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 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. |
| Subjective Preference - Comfort | Baseline and 2 weeks | 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 |
| Preference - Vision | Baseline and 2 weeks | 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 |
| Preference - Handling | Baseline and 2 weeks | 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 |
| Overall Preference | Baseline and 2 weeks | 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 |
| Investigator Acceptability | Baseline and 2 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Baseline Characteristics Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Dry eyes | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Overall Baseline Characteristics |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 29 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lenses | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar (nasal) | 1.00 units on a scale | Standard Deviation 0.71 |
| Habitual Lenses | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar (temporal) | 1.00 units on a scale | Standard Deviation 0.75 |
| Habitual Lenses | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar (superior) | 0.79 units on a scale | Standard Deviation 0.76 |
| Habitual Lenses | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar (inferior) | 0.79 units on a scale | Standard Deviation 0.76 |
| Habitual Lenses | Anterior Ocular Health - Bulbar and Limbal Redness | Limbal (nasal) | 0.71 units on a scale | Standard Deviation 1.07 |
| Habitual Lenses | Anterior Ocular Health - Bulbar and Limbal Redness | Limbal (temporal) | 0.71 units on a scale | Standard Deviation 1.07 |
| Habitual Lenses | Anterior Ocular Health - Bulbar and Limbal Redness | Limbal (superior) | 0.80 units on a scale | Standard Deviation 1.06 |
| Habitual Lenses | Anterior Ocular Health - Bulbar and Limbal Redness | Limbal (inferior) | 0.73 units on a scale | Standard Deviation 1.09 |
| Comfilcon A - Baseline | Anterior Ocular Health - Bulbar and Limbal Redness | Limbal (inferior) | 0.19 units on a scale | Standard Deviation 0.35 |
| Comfilcon A - Baseline | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar (nasal) | 0.67 units on a scale | Standard Deviation 0.45 |
| Comfilcon A - Baseline | Anterior Ocular Health - Bulbar and Limbal Redness | Limbal (nasal) | 0.21 units on a scale | Standard Deviation 0.38 |
| Comfilcon A - Baseline | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar (temporal) | 0.67 units on a scale | Standard Deviation 0.45 |
| Comfilcon A - Baseline | Anterior Ocular Health - Bulbar and Limbal Redness | Limbal (superior) | 0.21 units on a scale | Standard Deviation 0.38 |
| Comfilcon A - Baseline | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar (superior) | 0.63 units on a scale | Standard Deviation 0.46 |
| Comfilcon A - Baseline | Anterior Ocular Health - Bulbar and Limbal Redness | Limbal (temporal) | 0.21 units on a scale | Standard Deviation 0.38 |
| Comfilcon A - Baseline | Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar (inferior) | 0.62 units on a scale | Standard Deviation 0.45 |
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
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lenses | Anterior Ocular Health - Conjunctival Staining and Indentation | Nasal | 0.34 units on a scale | Standard Deviation 0.51 |
| Habitual Lenses | Anterior Ocular Health - Conjunctival Staining and Indentation | Superior | 0.07 units on a scale | Standard Deviation 0.18 |
| Habitual Lenses | Anterior Ocular Health - Conjunctival Staining and Indentation | Inferior | 0.18 units on a scale | Standard Deviation 0.43 |
| Habitual Lenses | Anterior Ocular Health - Conjunctival Staining and Indentation | Temporal | 0.23 units on a scale | Standard Deviation 0.4 |
| Comfilcon A - Baseline | Anterior Ocular Health - Conjunctival Staining and Indentation | Superior | 0.00 units on a scale | Standard Deviation 0 |
| Comfilcon A - Baseline | Anterior Ocular Health - Conjunctival Staining and Indentation | Temporal | 0.11 units on a scale | Standard Deviation 0.31 |
| Comfilcon A - Baseline | Anterior Ocular Health - Conjunctival Staining and Indentation | Nasal | 0.21 units on a scale | Standard Deviation 0.4 |
| Comfilcon A - Baseline | Anterior Ocular Health - Conjunctival Staining and Indentation | Inferior | 0.13 units on a scale | Standard Deviation 0.35 |
| Comfilcon A - 2 Weeks | Anterior Ocular Health - Conjunctival Staining and Indentation | Temporal | 0.29 units on a scale | Standard Deviation 0.51 |
| Comfilcon A - 2 Weeks | Anterior Ocular Health - Conjunctival Staining and Indentation | Superior | 0.15 units on a scale | Standard Deviation 0.31 |
| Comfilcon A - 2 Weeks | Anterior Ocular Health - Conjunctival Staining and Indentation | Nasal | 0.54 units on a scale | Standard Deviation 0.49 |
| Comfilcon A - 2 Weeks | Anterior Ocular Health - Conjunctival Staining and Indentation | Inferior | 0.19 units on a scale | Standard Deviation 0.38 |
| Conjunctival Indentation (2 Weeks) | Anterior Ocular Health - Conjunctival Staining and Indentation | Temporal | 0.38 units on a scale | Standard Deviation 0.5 |
| Conjunctival Indentation (2 Weeks) | Anterior Ocular Health - Conjunctival Staining and Indentation | Inferior | 0.21 units on a scale | Standard Deviation 0.38 |
| Conjunctival Indentation (2 Weeks) | Anterior Ocular Health - Conjunctival Staining and Indentation | Superior | 0.02 units on a scale | Standard Deviation 0.1 |
| Conjunctival Indentation (2 Weeks) | Anterior Ocular Health - Conjunctival Staining and Indentation | Nasal | 0.37 units on a scale | Standard Deviation 0.52 |
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
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lenses | Anterior Ocular Health - Corneal Staining | Nasal | 0.11 units on a scale | Standard Deviation 0.31 |
| Habitual Lenses | Anterior Ocular Health - Corneal Staining | Superior | 0.04 units on a scale | Standard Deviation 0.19 |
| Habitual Lenses | Anterior Ocular Health - Corneal Staining | Temporal | 0.00 units on a scale | Standard Deviation 0 |
| Habitual Lenses | Anterior Ocular Health - Corneal Staining | Inferior | 0.11 units on a scale | Standard Deviation 0.31 |
| Habitual Lenses | Anterior Ocular Health - Corneal Staining | Central | 0.00 units on a scale | Standard Deviation 0 |
| Comfilcon A - Baseline | Anterior Ocular Health - Corneal Staining | Inferior | 0.12 units on a scale | Standard Deviation 0.33 |
| Comfilcon A - Baseline | Anterior Ocular Health - Corneal Staining | Central | 0.00 units on a scale | Standard Deviation 0 |
| Comfilcon A - Baseline | Anterior Ocular Health - Corneal Staining | Nasal | 0.04 units on a scale | Standard Deviation 0.2 |
| Comfilcon A - Baseline | Anterior Ocular Health - Corneal Staining | Temporal | 0.00 units on a scale | Standard Deviation 0 |
| Comfilcon A - Baseline | Anterior Ocular Health - Corneal Staining | Superior | 0.04 units on a scale | Standard Deviation 0.2 |
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
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lenses | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral Conjunctival Hyperemia (Superior) | 0.75 units on a scale | Standard Deviation 0.81 |
| Habitual Lenses | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral Conjunctival Hyperemia (Inferior) | 0.71 units on a scale | Standard Deviation 0.6 |
| Habitual Lenses | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral Conjunctival Papillae (Superior) | 0.61 units on a scale | Standard Deviation 0.46 |
| Habitual Lenses | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral Conjunctival Papillae (Inferior) | 0.64 units on a scale | Standard Deviation 0.43 |
| Comfilcon A - Baseline | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral Conjunctival Papillae (Inferior) | 0.54 units on a scale | Standard Deviation 0.37 |
| Comfilcon A - Baseline | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral Conjunctival Hyperemia (Superior) | 0.48 units on a scale | Standard Deviation 0.33 |
| Comfilcon A - Baseline | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral Conjunctival Papillae (Superior) | 0.58 units on a scale | Standard Deviation 0.44 |
| Comfilcon A - Baseline | Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral Conjunctival Hyperemia (Inferior) | 0.50 units on a scale | Standard Deviation 0.35 |
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
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Population: One participant discontinued and therefore data was not included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses | Handling | 88 units on a scale | Standard Deviation 25 |
| Comfilcon A - Baseline | Handling | 89 units on a scale | Standard Deviation 16 |
| Comfilcon A - 2 Weeks | Handling | 94 units on a scale | Standard Deviation 9 |
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.
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses | Investigator Acceptability | Agree | 86 percentage of subjects |
| Habitual Lenses | Investigator Acceptability | Neither Agree nor Disagree | 14 percentage of subjects |
| Habitual Lenses | Investigator Acceptability | Disagree | 0 percentage of subjects |
| Comfilcon A - Baseline | Investigator Acceptability | Agree | 85 percentage of subjects |
| Comfilcon A - Baseline | Investigator Acceptability | Neither Agree nor Disagree | 15 percentage of subjects |
| Comfilcon A - Baseline | Investigator Acceptability | Disagree | 0 percentage of subjects |
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)
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses | Lens Fit Acceptance | 3.0 units on a scale | Standard Deviation 0.6 |
| Comfilcon A - Baseline | Lens Fit Acceptance | 3.5 units on a scale | Standard Deviation 0.7 |
| Comfilcon A - 2 Weeks | Lens Fit Acceptance | 3.3 units on a scale | Standard Deviation 0.4 |
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
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses | Lens Fit - Overall Stability | 2.8 units on a scale | Standard Deviation 0.7 |
| Comfilcon A - Baseline | Lens Fit - Overall Stability | 3.3 units on a scale | Standard Deviation 0.8 |
| Comfilcon A - 2 Weeks | Lens Fit - Overall Stability | 3.3 units on a scale | Standard Deviation 0.6 |
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.
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses | Lens Fit - Rotation | <=15 degrees | 93 percentage of eyes |
| Habitual Lenses | Lens Fit - Rotation | <=10 degrees | 93 percentage of eyes |
| Habitual Lenses | Lens Fit - Rotation | 0 degrees | 18 percentage of eyes |
| Habitual Lenses | Lens Fit - Rotation | <=5 degrees | 64 percentage of eyes |
| Habitual Lenses | Lens Fit - Rotation | >15 degrees | 7 percentage of eyes |
| Comfilcon A - Baseline | Lens Fit - Rotation | <=10 degrees | 86 percentage of eyes |
| Comfilcon A - Baseline | Lens Fit - Rotation | 0 degrees | 29 percentage of eyes |
| Comfilcon A - Baseline | Lens Fit - Rotation | <=5 degrees | 71 percentage of eyes |
| Comfilcon A - Baseline | Lens Fit - Rotation | <=15 degrees | 93 percentage of eyes |
| Comfilcon A - Baseline | Lens Fit - Rotation | >15 degrees | 7 percentage of eyes |
| Comfilcon A - 2 Weeks | Lens Fit - Rotation | >15 degrees | 7 percentage of eyes |
| Comfilcon A - 2 Weeks | Lens Fit - Rotation | <=15 degrees | 93 percentage of eyes |
| Comfilcon A - 2 Weeks | Lens Fit - Rotation | 0 degrees | 21 percentage of eyes |
| Comfilcon A - 2 Weeks | Lens Fit - Rotation | <=10 degrees | 89 percentage of eyes |
| Comfilcon A - 2 Weeks | Lens Fit - Rotation | <=5 degrees | 64 percentage of eyes |
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.
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Population: One participant discontinued and therefore data was not included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses | Overall Comfort | 80 units on a scale | Standard Deviation 16 |
| Comfilcon A - Baseline | Overall Comfort | 91 units on a scale | Standard Deviation 9 |
| Comfilcon A - 2 Weeks | Overall Comfort | 88 units on a scale | Standard Deviation 11 |
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
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses | Overall Preference | comfilcon A lenses | 50 percentage of subjects |
| Habitual Lenses | Overall Preference | No preference | 43 percentage of subjects |
| Habitual Lenses | Overall Preference | Habitual lenses | 7 percentage of subjects |
| Comfilcon A - Baseline | Overall Preference | comfilcon A lenses | 46 percentage of subjects |
| Comfilcon A - Baseline | Overall Preference | No preference | 23 percentage of subjects |
| Comfilcon A - Baseline | Overall Preference | Habitual lenses | 31 percentage of subjects |
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.
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Population: One participant discontinued and therefore data was not included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses | Overall Satisfaction | 90 units on a scale | Standard Deviation 10 |
| Comfilcon A - Baseline | Overall Satisfaction | 92 units on a scale | Standard Deviation 9 |
| Comfilcon A - 2 Weeks | Overall Satisfaction | 89 units on a scale | Standard Deviation 10 |
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.
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post
Population: One participant discontinued and therefore data was not included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses | Overall Vision | 75 units on a scale | Standard Deviation 17 |
| Comfilcon A - Baseline | Overall Vision | 85 units on a scale | Standard Deviation 15 |
| Comfilcon A - 2 Weeks | Overall Vision | 80 units on a scale | Standard Deviation 18 |
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
Time frame: Baseline and 2 weeks
Population: Missing data for handling preference for one participant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses | Preference - Handling | No preference | 64.3 percentage of subjects |
| Habitual Lenses | Preference - Handling | Habitual lenses | 7.1 percentage of subjects |
| Habitual Lenses | Preference - Handling | Missing | 7.1 percentage of subjects |
| Habitual Lenses | Preference - Handling | comfilcon A lenses | 21.4 percentage of subjects |
| Comfilcon A - Baseline | Preference - Handling | No preference | 54 percentage of subjects |
| Comfilcon A - Baseline | Preference - Handling | comfilcon A lenses | 31 percentage of subjects |
| Comfilcon A - Baseline | Preference - Handling | Missing | 0 percentage of subjects |
| Comfilcon A - Baseline | Preference - Handling | Habitual lenses | 15 percentage of subjects |
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
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses | Preference - Vision | comfilcon A XR lenses | 50.0 percentage of subjects |
| Habitual Lenses | Preference - Vision | No preference | 28.6 percentage of subjects |
| Habitual Lenses | Preference - Vision | Habitual lenses | 21.4 percentage of subjects |
| Comfilcon A - Baseline | Preference - Vision | comfilcon A XR lenses | 46.2 percentage of subjects |
| Comfilcon A - Baseline | Preference - Vision | No preference | 15.4 percentage of subjects |
| Comfilcon A - Baseline | Preference - Vision | Habitual lenses | 38.5 percentage of subjects |
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
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses | Subjective Preference - Comfort | comfilcon A lenses | 57 percentage of subjects |
| Habitual Lenses | Subjective Preference - Comfort | No preference | 43 percentage of subjects |
| Habitual Lenses | Subjective Preference - Comfort | Habitual lenses | 0 percentage of subjects |
| Comfilcon A - Baseline | Subjective Preference - Comfort | comfilcon A lenses | 69 percentage of subjects |
| Comfilcon A - Baseline | Subjective Preference - Comfort | No preference | 23 percentage of subjects |
| Comfilcon A - Baseline | Subjective Preference - Comfort | Habitual lenses | 8 percentage of subjects |
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.
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Population: One participant discontinued and therefore data was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lenses | Visual Acuity | High Contrast High Illumination (monocular) | 0.06 LogMAR | Standard Deviation 0.14 |
| Habitual Lenses | Visual Acuity | High Contrast High Illumination (binocular) | -0.04 LogMAR | Standard Deviation 0.09 |
| Habitual Lenses | Visual Acuity | High Contrast Low Illumination (monocular) | 0.19 LogMAR | Standard Deviation 0.13 |
| Habitual Lenses | Visual Acuity | High Contrast Low Illumination (binocular) | 0.10 LogMAR | Standard Deviation 0.09 |
| Comfilcon A - Baseline | Visual Acuity | High Contrast Low Illumination (binocular) | 0.15 LogMAR | Standard Deviation 0.1 |
| Comfilcon A - Baseline | Visual Acuity | High Contrast High Illumination (monocular) | 0.06 LogMAR | Standard Deviation 0.08 |
| Comfilcon A - Baseline | Visual Acuity | High Contrast Low Illumination (monocular) | 0.20 LogMAR | Standard Deviation 0.09 |
| Comfilcon A - Baseline | Visual Acuity | High Contrast High Illumination (binocular) | 0.00 LogMAR | Standard Deviation 0.07 |
| Comfilcon A - 2 Weeks | Visual Acuity | High Contrast Low Illumination (binocular) | 0.17 LogMAR | Standard Deviation 0.14 |
| Comfilcon A - 2 Weeks | Visual Acuity | High Contrast High Illumination (binocular) | -0.03 LogMAR | Standard Deviation 0.09 |
| Comfilcon A - 2 Weeks | Visual Acuity | High Contrast Low Illumination (monocular) | 0.23 LogMAR | Standard Deviation 0.13 |
| Comfilcon A - 2 Weeks | Visual Acuity | High Contrast High Illumination (monocular) | 0.07 LogMAR | Standard Deviation 0.14 |