Myopia
Conditions
Keywords
ocular irritation
Brief summary
This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.
Interventions
DEVICESofLens in investigational solution
SofLens in investigational solution, worn on a daily disposable basis for 7 days.
DEVICESofLens in currently marketed solution
SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must 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 contact lens correction from -0.50 D to -6.00 D in each eye. * Subjects must be habitual wearers of daily disposable or planned replacement (at least every 3 months) soft contact lenses. * Subjects must live/work in an urban environment at least 6 hours per day and for at least 4 days per week throughout the duration of the study. * Subjects must be willing and able to wear the study lenses on a daily wear basis while in an urban environment. * Subjects living/working in the urban environment must feel challenged by harsh, drying outdoor conditions (ie dust, pollution, smog). * Subjects must feel that being in an urban environment has a negative effect on their lens wearing experience. * Subjects must have access to an internet connection and be able to send and receive email.
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 with any grade 2 or greater finding during the slit lamp examination * 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 with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study. * Subjects who are allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | At 2 weeks follow up | Graded 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). The outcome measure is any finding \> grade 2, across abnormalities. |
| Visual Acuity | At 2 weeks follow up | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms and Complaints | At 2 weeks follow up | Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints. Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, and Overall impression. |
Countries
United States
Participant flow
Recruitment details
There were 438 eligible participants (876 eyes) enrolled.
Participants by arm
| Arm | Count |
|---|---|
| SofLens in Investigational Solution Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.
SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. | 222 |
| SofLens in Currently Marketed Solution SofLens daily disposable contact lens packaged in currently marketed storage solution.
SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. | 215 |
| Total | 437 |
Baseline characteristics
| Characteristic | SofLens in Investigational Solution | SofLens in Currently Marketed Solution | Total |
|---|---|---|---|
| Age, Continuous | 27.9 years | 27.2 years | 27.6 years |
| Sex: Female, Male Female | 164 Participants | 146 Participants | 310 Participants |
| Sex: Female, Male Male | 58 Participants | 69 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 222 | 0 / 216 |
| serious Total, serious adverse events | 0 / 222 | 0 / 216 |
Outcome results
Primary
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded 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). The outcome measure is any finding \> grade 2, across abnormalities.
Time frame: At 2 weeks follow up
Population: Dispensed eyes with nonmissing scores in each treatment group are included in the analysis population.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| SofLens in Investigational Solution | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 0 eyes |
| SofLens in Currently Marketed Solution | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 0 eyes |
Primary
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time frame: At 2 weeks follow up
Population: Eyes assessed for visual acuity at the 2 week follow up visit are included in the analysis population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SofLens in Investigational Solution | Visual Acuity | -0.051 logMAR | Standard Deviation 0.062 |
| SofLens in Currently Marketed Solution | Visual Acuity | -0.046 logMAR | Standard Deviation 0.061 |
Secondary
Symptoms and Complaints
Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints. Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, and Overall impression.
Time frame: At 2 weeks follow up
Population: Eyes assessed for symptoms/complaints at the 2 week follow up visit are included in the analysis population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SofLens in Investigational Solution | Symptoms and Complaints | Itchiness | 84.5 score on a scale | Standard Deviation 19.1 |
| SofLens in Investigational Solution | Symptoms and Complaints | Vision in low light | 85.4 score on a scale | Standard Deviation 14.6 |
| SofLens in Investigational Solution | Symptoms and Complaints | Ease of handling/insertion | 73.1 score on a scale | Standard Deviation 24.1 |
| SofLens in Investigational Solution | Symptoms and Complaints | Lens cleanness upon insertion | 90.2 score on a scale | Standard Deviation 14.2 |
| SofLens in Investigational Solution | Symptoms and Complaints | Redness | 86.3 score on a scale | Standard Deviation 17.4 |
| SofLens in Investigational Solution | Symptoms and Complaints | Lens cleanness upon removal | 84.6 score on a scale | Standard Deviation 15.5 |
| SofLens in Investigational Solution | Symptoms and Complaints | Dryness | 74.2 score on a scale | Standard Deviation 24.2 |
| SofLens in Investigational Solution | Symptoms and Complaints | Overall impression | 73.7 score on a scale | Standard Deviation 21.2 |
| SofLens in Investigational Solution | Symptoms and Complaints | Vision upon insertion | 86.7 score on a scale | Standard Deviation 14.4 |
| SofLens in Investigational Solution | Symptoms and Complaints | Burning/stinging upon insertion | 83.2 score on a scale | Standard Deviation 20.5 |
| SofLens in Investigational Solution | Symptoms and Complaints | Ease of handling/removal | 87.1 score on a scale | Standard Deviation 16.2 |
| SofLens in Investigational Solution | Symptoms and Complaints | Comfort upon insertion | 78.2 score on a scale | Standard Deviation 20.4 |
| SofLens in Investigational Solution | Symptoms and Complaints | Vision | 87.7 score on a scale | Standard Deviation 14.2 |
| SofLens in Investigational Solution | Symptoms and Complaints | Overall comfort | 77.6 score on a scale | Standard Deviation 21 |
| SofLens in Investigational Solution | Symptoms and Complaints | Comfort at end of day | 70.3 score on a scale | Standard Deviation 23.8 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Overall comfort | 79.9 score on a scale | Standard Deviation 20.9 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Comfort at end of day | 70.5 score on a scale | Standard Deviation 23.7 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Ease of handling/insertion | 76.3 score on a scale | Standard Deviation 24.1 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Ease of handling/removal | 87.9 score on a scale | Standard Deviation 16.2 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Dryness | 74.5 score on a scale | Standard Deviation 24.2 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Itchiness | 87.7 score on a scale | Standard Deviation 19.1 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Redness | 89.2 score on a scale | Standard Deviation 17.4 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Vision upon insertion | 89.2 score on a scale | Standard Deviation 14.4 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Vision | 88.7 score on a scale | Standard Deviation 14.2 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Vision in low light | 86.7 score on a scale | Standard Deviation 14.6 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Lens cleanness upon insertion | 91.3 score on a scale | Standard Deviation 14.2 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Lens cleanness upon removal | 84.1 score on a scale | Standard Deviation 15.5 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Overall impression | 75.9 score on a scale | Standard Deviation 21.1 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Burning/stinging upon insertion | 86.8 score on a scale | Standard Deviation 20.5 |
| SofLens in Currently Marketed Solution | Symptoms and Complaints | Comfort upon insertion | 82.7 score on a scale | Standard Deviation 20.4 |