Myopia
Conditions
Brief summary
The purpose of this study is to compare the clinical performance of two contact lenses.
Interventions
DEVICEsenofilcon A
soft contact lens, 2-week replacement indicated
DEVICElotrafilcon B
soft contact lens with a 4-week replacement indicated.
Sponsors
Visioncare Research Ltd.
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Existing daily soft lens wearer. * Require a distance visual correction in both eyes. * Have a contact lens spherical distance refraction between -1.00D and -6.00D. * Have refractive astigmatism less than or equal to 1.00D in both eyes. * Achieve 20/30 or better corrected distance acuity. * Have normal eyes with no evidence of abnormality or disease.
Exclusion criteria
* Requires presbyopic correction. * Requires ocular medications. * Grade 3 or 4 ocular abnormalities. * Grade 3 corneal staining in more than one region. * Has had refractive surgery. * Any other injury or ocular surgery within 8 weeks prior to study enrollment. * Has abnormal lacrimal secretions. * Pre-existing ocular irritation that would preclude contact lens fitting. * Has keratoconus or other corneal irregularity. * Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks. * Wears habitual contact lenses that are toric, multifocal or worn extended wear. * Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear. * Diabetic. * Infectious or immunosuppressive disease. * History of chronic eye disease (e.g glaucoma or age related macular degeneration). * Pregnancy, lactation or planning pregnancy at time of enrollment. * Participation in any concurrent clinical trial or in another trial in the last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Corneal Staining | 2 weeks | The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe. |
| Visual Acuity | 2 weeks | Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal. |
| Overall Comfort | 2 weeks | After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Limbal Redness | 2 weeks | The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe |
| Bulbar Redness | 2 weeks | The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe |
| Symptoms of Dryness | 2 weeks | Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon A contact lens | 184 |
| Lotrafilcon B contact lens | 195 |
| Total | 379 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Lens issue | 2 | 2 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Senofilcon A | Lotrafilcon B | Total |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 7 | 29.3 years STANDARD_DEVIATION 6.9 | 29.5 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment United States | 184 participants | 195 participants | 379 participants |
| Sex: Female, Male Female | 125 Participants | 136 Participants | 261 Participants |
| Sex: Female, Male Male | 59 Participants | 59 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 184 | 0 / 195 |
| serious Total, serious adverse events | 0 / 184 | 0 / 195 |
Outcome results
Primary
Average Corneal Staining
The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: 2 weeks
Population: Analysis included all subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Average Corneal Staining | 0.157 units on a scale | Standard Error 0.018 |
| Lotrafilcon B | Average Corneal Staining | 0.170 units on a scale | Standard Error 0.018 |
Comparison: The alternative hypothesis is that senofilcon A contact lenses have non-inferior (less than or equal to) average corneal staining than lotrafilcon B after two weeks of wear.97.46% CI: [-0.058, 0.031]Mixed Models Analysis
Primary
Overall Comfort
After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time frame: 2 weeks
Population: Analysis includes subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Overall Comfort | 3.938 units on a scale | Standard Error 0.09 |
| Lotrafilcon B | Overall Comfort | 3.536 units on a scale | Standard Error 0.091 |
Comparison: The alternative hypothesis is that senofilcon A contact lenses have a higher rating of overall comfort than lotrafilcon B after two weeks of wear.97.46% CI: [0.117, 0.402]Mixed Models Analysis
Primary
Overall Comfort
After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time frame: 2 weeks and 4 weeks
Population: Analysis includes all subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Overall Comfort | 3.534 units on a scale | Standard Error 0.111 |
| Lotrafilcon B | Overall Comfort | 3.436 units on a scale | Standard Error 0.118 |
Comparison: The alternative hypothesis is that lotrafilcon B contact lenses have a lower rating of overall comfort after 4 weeks of wear compared to after 2 weeks of wear.97.46% CI: [-0.218, 0.098]Mixed Models Analysis
Primary
Visual Acuity
Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Visual Acuity | -0.012 logMAR units | Standard Error 0.003 |
| Lotrafilcon B | Visual Acuity | -0.002 logMAR units | Standard Error 0.003 |
Comparison: The alternative hypothesis is that senofilcon A contact lenses are non-inferior (less than or equal to)in visual acuity to lotrafilcon B contact lenses after two weeks of wear.97.46% CI: [-0.021, -0.01]Mixed Models Analysis
Secondary
Bulbar Redness
The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time frame: 2 weeks
Population: Analysis includes subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Bulbar Redness | 0.465 units on a scale | Standard Error 0.031 |
| Lotrafilcon B | Bulbar Redness | 0.532 units on a scale | Standard Error 0.03 |
Comparison: The alternative hypothesis is that senofilcon A contact lenses are non-inferior in bulbar redness to lotrafilcon B contact lenses after two weeks of wear.98.2% CI: [-0.068, 0.008]Mixed Models Analysis
Secondary
Limbal Redness
The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time frame: 2 weeks
Population: Analysis includes subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Limbal Redness | 0.376 units on a scale | Standard Error 0.031 |
| Lotrafilcon B | Limbal Redness | 0.499 units on a scale | Standard Error 0.03 |
Comparison: The alternative hypothesis is that senofilcon A contact lenses are non-inferior in limbal redness 5 to lotrafilcon B contact lenses after two weeks of wear.98.2% CI: [-0.123, -0.051]Mixed Models Analysis
Secondary
Symptoms of Dryness
Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None
Time frame: 2 weeks
Population: Analysis includes subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Symptoms of Dryness | 2.003 units on a scale | Standard Error 0.087 |
| Lotrafilcon B | Symptoms of Dryness | 2.414 units on a scale | Standard Error 0.088 |
Comparison: The alternative hypothesis is that senofilcon A contact lenses have less frequency of dryness than lotrafilcon B contact lenes after two weeks of wear.98.2% CI: [-0.411, -0.117]Mixed Models Analysis