Myopia
Conditions
Keywords
contact lens
Brief summary
The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants \[PDAs\], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.
Interventions
DEVICEExperimental- Soflens
A new pair of lenses will be worn each day while the subject is in the study
DEVICEMarketed - Soflens
A new pair of lenses will be worn each day while the subject is in the study.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes
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 be free of any anterior segment disorders. * Subjects must be adapted soft contact 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 willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study. * Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.
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 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 have had any corneal surgery (eg, refractive surgery). * Subjects who are allergic to any component in the study care products. * Subjects may not use their habitual rewetting drops while participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial Lens Performance Survey | At dispensing | A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score. |
Countries
United States
Participant flow
Recruitment details
There were 441 participants (882 eyes) enrolled, 221 in the test group and 220 in the control group. There were 434 eligible participants (868 eyes) who participated in the study, 216 in the test group and 218 in the control group.
Participants by arm
| Arm | Count |
|---|---|
| Experimental- Soflens Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.
Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study | 215 |
| Marketed - Soflens Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.
Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. | 216 |
| Total | 431 |
Baseline characteristics
| Characteristic | Experimental- Soflens | Marketed - Soflens | Total |
|---|---|---|---|
| Age, Continuous | 27.1 years | 26.6 years | 26.8 years |
| Sex: Female, Male Female | 140 Participants | 153 Participants | 293 Participants |
| Sex: Female, Male Male | 75 Participants | 63 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 221 | 0 / 220 |
| serious Total, serious adverse events | 0 / 221 | 0 / 220 |
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: 2 weeks
Population: There were 438 eyes in the test group and 434 eyes in the control group that were assessed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Experimental- Soflens | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 0 eyes |
| Marketed - Soflens | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 0 eyes |
Secondary
Initial Lens Performance Survey
A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score.
Time frame: At dispensing
Population: There were 426 eyes in the test group and 424 eyes in the control group that were assessed for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental- Soflens | Initial Lens Performance Survey | Lens Cleanness Upon Insertion | 95.4 score on a scale | Standard Deviation 10.8 |
| Experimental- Soflens | Initial Lens Performance Survey | Vision Upon Insertion | 89.3 score on a scale | Standard Deviation 15.5 |
| Experimental- Soflens | Initial Lens Performance Survey | Burning/stinging upon insertion | 91.6 score on a scale | Standard Deviation 18.7 |
| Experimental- Soflens | Initial Lens Performance Survey | Comfort Upon Insertion | 83.8 score on a scale | Standard Deviation 21.1 |
| Experimental- Soflens | Initial Lens Performance Survey | Ease of Handling/Insertion | 77.2 score on a scale | Standard Deviation 26.2 |
| Marketed - Soflens | Initial Lens Performance Survey | Vision Upon Insertion | 88.4 score on a scale | Standard Deviation 15.6 |
| Marketed - Soflens | Initial Lens Performance Survey | Comfort Upon Insertion | 83.9 score on a scale | Standard Deviation 21.2 |
| Marketed - Soflens | Initial Lens Performance Survey | Lens Cleanness Upon Insertion | 94.9 score on a scale | Standard Deviation 10.9 |
| Marketed - Soflens | Initial Lens Performance Survey | Ease of Handling/Insertion | 79.4 score on a scale | Standard Deviation 26.3 |
| Marketed - Soflens | Initial Lens Performance Survey | Burning/stinging upon insertion | 91.0 score on a scale | Standard Deviation 18.7 |