Myopia
Conditions
Keywords
contact lens
Brief summary
The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.
Interventions
DEVICERedesigned Purevision Contact Lens
Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
DEVICEPureVision Contact Lens
Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have clear central corneas and be free of any anterior segment disorders. * Subjects must be adapted wearers of one of the listed contact lenses * Subjects must be myopic * Subjects must use a lens care system on a regular basis.
Exclusion criteria
* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months. * Subjects with any systemic disease affecting ocular health. * 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 are using any ocular medication. * Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Subjects who have had any corneal surgery (eg, refractive surgery). * Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms and Complaints | 1 month | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 1 month | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | 1 month | 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. |
Countries
United States
Participant flow
Recruitment details
There were 188 participants enrolled into each group, for a total of 376 participants enrolled. There were 185 participants in the redesigned group and 183 participants in the control group who were eligible and dispensed lenses.
Participants by arm
| Arm | Count |
|---|---|
| Redesigned Purevision Contact Lens Redesigned Bausch & Lomb PureVision contact lens
Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. | 185 |
| PureVision Contact Lens Bausch & Lomb PureVision contact lens
PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. | 183 |
| Total | 368 |
Baseline characteristics
| Characteristic | Redesigned Purevision Contact Lens | PureVision Contact Lens | Total |
|---|---|---|---|
| Age, Continuous | 32.0 years | 30.6 years | 31.3 years |
| Sex: Female, Male Female | 136 Participants | 130 Participants | 266 Participants |
| Sex: Female, Male Male | 49 Participants | 53 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 185 | 0 / 183 |
| serious Total, serious adverse events | 0 / 185 | 0 / 183 |
Outcome results
Primary
Symptoms and Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.
Time frame: 1 month
Population: There were 185 participants (370 eyes) in the redesigned group and 183 participants (366 eyes) in the control group who were eligible and dispensed lenses. There were 368 dispensed eyes in the redesigned group and 360 dispensed eyes in the control group evaluable for the analysis population for the assessment of symptoms and complaints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Overall impression | 72.8 score on a scale | Standard Deviation 24.7 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Dryness | 75.1 score on a scale | Standard Deviation 23.8 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Lens handling upon insertion | 83.2 score on a scale | Standard Deviation 17.7 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Comfort upon insertion | 78.1 score on a scale | Standard Deviation 21.7 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Burning/stinging upon insertion | 84.6 score on a scale | Standard Deviation 19 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Comfort throughout the day | 75.1 score on a scale | Standard Deviation 22.2 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | End of day comfort | 67.6 score on a scale | Standard Deviation 24.8 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Lens awareness | 76.4 score on a scale | Standard Deviation 22.6 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Lens cleanliness | 84.5 score on a scale | Standard Deviation 16.5 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Irritation | 76.6 score on a scale | Standard Deviation 22.4 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Itching | 85.7 score on a scale | Standard Deviation 18.5 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Redness | 88.5 score on a scale | Standard Deviation 17.6 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Vision | 82.9 score on a scale | Standard Deviation 19.7 |
| Redesigned Purevision Contact Lens | Symptoms and Complaints | Lens handling upon removal | 88.3 score on a scale | Standard Deviation 15.5 |
| PureVision Contact Lens | Symptoms and Complaints | Redness | 86.6 score on a scale | Standard Deviation 17.6 |
| PureVision Contact Lens | Symptoms and Complaints | Lens cleanliness | 81.5 score on a scale | Standard Deviation 16.5 |
| PureVision Contact Lens | Symptoms and Complaints | Lens handling upon removal | 86.6 score on a scale | Standard Deviation 15.5 |
| PureVision Contact Lens | Symptoms and Complaints | Lens handling upon insertion | 83.6 score on a scale | Standard Deviation 17.7 |
| PureVision Contact Lens | Symptoms and Complaints | Irritation | 73.4 score on a scale | Standard Deviation 22.4 |
| PureVision Contact Lens | Symptoms and Complaints | Comfort upon insertion | 74.6 score on a scale | Standard Deviation 21.7 |
| PureVision Contact Lens | Symptoms and Complaints | Vision | 82.0 score on a scale | Standard Deviation 19.7 |
| PureVision Contact Lens | Symptoms and Complaints | Burning/stinging upon insertion | 83.2 score on a scale | Standard Deviation 19 |
| PureVision Contact Lens | Symptoms and Complaints | Itching | 85.2 score on a scale | Standard Deviation 18.5 |
| PureVision Contact Lens | Symptoms and Complaints | Comfort throughout the day | 73.0 score on a scale | Standard Deviation 22.2 |
| PureVision Contact Lens | Symptoms and Complaints | Dryness | 73.5 score on a scale | Standard Deviation 23.9 |
| PureVision Contact Lens | Symptoms and Complaints | End of day comfort | 65.1 score on a scale | Standard Deviation 24.9 |
| PureVision Contact Lens | Symptoms and Complaints | Overall impression | 67.7 score on a scale | Standard Deviation 24.7 |
| PureVision Contact Lens | Symptoms and Complaints | Lens awareness | 72.1 score on a scale | Standard Deviation 22.6 |
Secondary
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: 1 month
Population: There were 188 participants (376 eyes) enrolled into each group, for a total of 376 participants enrolled (752 eyes). There were 372 eyes in the redesigned group and 374 eyes in the control group assessed for slit lamp findings during the study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Redesigned Purevision Contact Lens | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 5 eyes |
| PureVision Contact Lens | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 5 eyes |
Secondary
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time frame: 1 month
Population: There were 185 participants (370 eyes) in the redesigned group and 183 participants (366 eyes) in the control group who were eligible and dispensed lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Redesigned Purevision Contact Lens | Visual Acuity | -0.028 logMAR | Standard Deviation 0.068 |
| PureVision Contact Lens | Visual Acuity | -0.021 logMAR | Standard Deviation 0.068 |