Myopia
Conditions
Brief summary
The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.
Interventions
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye * Subjects must have clear central corneas and be free of any anterior segment disorders. * Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand. * Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye. * Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week. * Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders). * Subjects must habitually wear soft contact lens. * Subject must have no active ocular disease or allergic conjunctivitis. * Subject must not be using any topical ocular medications. * Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses. * Subjects must habitually use a lens care product for cleaning, disinfection, and storage.
Exclusion criteria
* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months. * Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study. * Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Subjects with an active ocular disease or who are using any ocular medication. * Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses. * Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses. * Subjects with an ocular astigmatism of 1.00 D or greater in either eye. * Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye. * Subjects with any Grade 2 or greater finding during the slit lamp examination. * Subjects with corneal infiltrates, of ANY GRADE, are not eligible. * Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Subjects with any scar or neovascularization within the central 4 mm of the cornea. * Subjects who are aphakic. * Subjects who are amblyopic. * Subjects who have had any corneal surgery (eg, refractive surgery). * Subjects who are allergic to any component in the study care products. * Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? | 7 days | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: How would you say these contact lenses compare overall with the contact lenses you usually use? Prefer study lenses Prefer usual lenses About the same as usual lenses |
| Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long. | 7 days | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: These contact lenses deliver exceptional clarity and comfort all day long. Prefer study lenses Prefer usual lenses About the same as usual lenses |
| Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes. | 7 days | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: These contact lenses help maintain healthy, white eyes. Prefer study lenses Prefer usual lenses About the same as usual lenses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Performance Assessment | 2 weeks | High Contrast Distance logMAR Lens VA Change From Baseline to Week 2. |
| Any Graded Slit Lamp Finding > 2 | 2 weeks | Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Silicone Hydrogel Contact Lens Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Silicone Hydrogel Contact Lens | 396 |
| Total | 396 |
Baseline characteristics
| Characteristic | Silicone Hydrogel Contact Lens |
|---|---|
| Age, Continuous | 26.8 years STANDARD_DEVIATION 4.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 44 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 327 Participants |
| Sex: Female, Male Female | 278 Participants |
| Sex: Female, Male Male | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 396 |
| serious Total, serious adverse events | 0 / 396 |
Outcome results
Primary
Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: How would you say these contact lenses compare overall with the contact lenses you usually use? Prefer study lenses Prefer usual lenses About the same as usual lenses
Time frame: 7 days
Population: There were 380 eligible subjects with lenses dispensed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Silicone Hydrogel Contact Lens | Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? | Prefer study lenses | 195 Participants |
| Silicone Hydrogel Contact Lens | Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? | Prefer usual lenses | 93 Participants |
| Silicone Hydrogel Contact Lens | Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? | About the same as usual lens | 92 Participants |
Primary
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: These contact lenses deliver exceptional clarity and comfort all day long. Prefer study lenses Prefer usual lenses About the same as usual lenses
Time frame: 7 days
Population: There were 380 eligible subjects with lenses dispensed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Silicone Hydrogel Contact Lens | Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long. | Prefer study lenses | 199 Participants |
| Silicone Hydrogel Contact Lens | Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long. | Prefer usual lenses | 80 Participants |
| Silicone Hydrogel Contact Lens | Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long. | About the same as usual lens | 101 Participants |
Primary
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: These contact lenses help maintain healthy, white eyes. Prefer study lenses Prefer usual lenses About the same as usual lenses
Time frame: 7 days
Population: There were 380 eligible subjects with lenses dispensed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Silicone Hydrogel Contact Lens | Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes. | Prefer study lenses | 162 Participants |
| Silicone Hydrogel Contact Lens | Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes. | Prefer usual lenses | 51 Participants |
| Silicone Hydrogel Contact Lens | Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes. | About the same as usual lens | 167 Participants |
Secondary
Any Graded Slit Lamp Finding > 2
Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.
Time frame: 2 weeks
Population: Percentages are based on the number of dispensed eyes with non-missing scores.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Silicone Hydrogel Contact Lens | Any Graded Slit Lamp Finding > 2 | 2 Eyes |
Secondary
Lens Performance Assessment
High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.
Time frame: 2 weeks
Population: High contrast distance lens visual acuity (VA) was assessed at Screening/Dispensing on the Test (newly dispensed) lenses, and at the follow-up visit(s). The population included subjects with baseline and at least one post-baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silicone Hydrogel Contact Lens | Lens Performance Assessment | 0.004 Log of Minimum Angle of Resolution VA | Standard Deviation 0.067 |