Vision Disorders
Conditions
Brief summary
This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.
Interventions
DEVICEPureVision Multi-Focal contact lenses
Contact lenses to be worn on a daily wear basis for 2 weeks.
DEVICESofLens59 contact lens
Contact lenses to be worn on a daily wear basis for 2 weeks.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 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 adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks. * Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.
Exclusion criteria
* Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation. * Subjects with any systemic disease affecting ocular health * Subjects with an active ocular disease or using any ocular medication. * Subjects who have had any corneal surgery (eg, refractive surgery).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. | 2 weeks | Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings of Eye Strain | 2 week visit | Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 25 sites, by 25 Investigators in the United States (US). First participant enrollment was 09/28/2009 and last participant exited the study 11/09/2009
Pre-assignment details
272 participants (544 eyes) were enrolled in the study, 7 participants were ineligible at baseline, 265 participants were eligible. 259 participants (518 eyes) completed the study.
Participants by arm
| Arm | Count |
|---|---|
| PureVision Multi-Focal Contact Lenses | 133 |
| SofLens59 Contact Lens | 132 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | ineligible | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Study related symptoms & complaints | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | PureVision Multi-Focal Contact Lenses | SofLens59 Contact Lens | Total |
|---|---|---|---|
| Age, Customized 30-35 years of age | 68 participants | 67 participants | 135 participants |
| Age, Customized 36 -40 years of age | 65 participants | 65 participants | 130 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 11 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 14 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 110 Participants | 104 Participants | 214 Participants |
| Sex: Female, Male Female | 114 Participants | 97 Participants | 211 Participants |
| Sex: Female, Male Male | 19 Participants | 35 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 270 | 0 / 274 |
| serious Total, serious adverse events | 0 / 270 | 0 / 274 |
Outcome results
Primary
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.
Time frame: 2 weeks
Population: All Eligible, Dispensed Eyes with non-missing scores
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PureVision Multi-Focal Contact Lenses | Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. | 2 eyes |
| SofLens59 Contact Lens | Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. | 0 eyes |
Secondary
Subjective Ratings of Eye Strain
Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always
Time frame: 2 week visit
Population: All Eligible, Dispensed Eyes, CISS Composite Score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PureVision Multi-Focal Contact Lenses | Subjective Ratings of Eye Strain | 9.9 CISS Composite Score | Standard Deviation 9.6 |
| SofLens59 Contact Lens | Subjective Ratings of Eye Strain | 9.0 CISS Composite Score | Standard Deviation 9.5 |