Myopia
Conditions
Keywords
contact lens
Brief summary
The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.
Interventions
Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
DEVICEB&L PureVision Contact Lens
Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have clear central corneas and be free of any anterior segment disorders. * Subjects must be myopic, and wear contact lenses in each eye. * Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.
Exclusion criteria
* Subjects who are older than age 40 on the date the informed consent (ICF) is signed. * 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 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 who are allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (VA) | 4 visits over 3 months | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp > Grade 2 | 3 months | Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses. |
Participant flow
Recruitment details
This was a three month study enrolling 166 participants from 12 investigative sites in the United States. First participant was enroled on 08/08/2011, and last participant exited the study on 12/08/2011.
Pre-assignment details
166 participants were enrolled in the study with 158 participants completing the study. A minimum of 68 participants were to be of Japanese descent (both maternal and paternal grandparents born in Japan) for submission to the Japanese Regulatory Agency.
Participants by arm
| Arm | Count |
|---|---|
| B&L Investigational Contact Lens The Bausch + Lomb investigational silicone hydrogel contact lens
B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. | 83 |
| B&L PureVision Contact Lens The Bausch + Lomb PureVision silicone hydrogel contact lens
B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. | 83 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cannot maintain visits | 0 | 1 |
| Overall Study | Lack of Motivation | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Symptoms/complaints | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | B&L Investigational Contact Lens | Total | B&L PureVision Contact Lens |
|---|---|---|---|
| Age, Continuous | 29.0 years | 29.0 years | 29.0 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 53 Participants | 108 Participants | 55 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 49 Participants | 24 Participants |
| Region of Enrollment United States | 83 participants | 166 participants | 83 participants |
| Sex: Female, Male Female | 58 Participants | 108 Participants | 50 Participants |
| Sex: Female, Male Male | 25 Participants | 58 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 83 | 0 / 83 |
| serious Total, serious adverse events | 0 / 83 | 0 / 83 |
Outcome results
Primary
Visual Acuity (VA)
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.
Time frame: 4 visits over 3 months
Population: All Eligible, Dispensed Eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| B&L Investigational Contact Lens | Visual Acuity (VA) | -0.033 LogMAR | Standard Deviation 0.054 |
| B&L PureVision Contact Lens | Visual Acuity (VA) | -0.038 LogMAR | Standard Deviation 0.054 |
Secondary
Slit Lamp > Grade 2
Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.
Time frame: 3 months
Population: Number of dispensed eyes with non-missing scores in each treatment group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B&L Investigational Contact Lens | Slit Lamp > Grade 2 | 2 eyes (2 per participant) |
| B&L PureVision Contact Lens | Slit Lamp > Grade 2 | 5 eyes (2 per participant) |