Presbyopia
Conditions
Brief summary
The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.
Interventions
DEVICELD118033 contact lens
Multifocal contact lens worn on a daily wear basis for 1 week
DEVICEPureVision multifocal contact lens
PureVision multifocal contact lens worn on a daily wear basis for 1 week.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have physiologically normal anterior segments. * Be adapted wearers of soft contact lenses and wear a lens in each eye. * Be presbyopic and require near add correction in each eye. * Have no active ocular disease or allergic conjunctivitis. * Must not be using any topical ocular medications.
Exclusion criteria
* Any Grade 2 or greater finding during the slit lamp examination. * Any scar or neovascularization within the central 4mm of the cornea. * Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Allergic to any component in the study products. * Any systemic disease affecting ocular health. * Using any systemic or topical medications that will affect ocular physiology or lens performance. * An active ocular disease, any corneal infiltrative response or are using any ocular medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | At 1 week follow up | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms/Complaints | At 1 week follow up | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. |
Countries
United States
Participant flow
Recruitment details
A total of 126 participants (252 eyes) were enrolled. One-half of the participants were randomized to receive the investigational contact lens during the first crossover period, and the other half were randomized to receive the PureVision contact lens during the first crossover period. The participants crossed over to the other group at 1 week.
Participants by arm
| Arm | Count |
|---|---|
| Overall All participants/eyes received both treatment groups. | 124 |
| Total | 124 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 47.0 years STANDARD_DEVIATION 4.7 |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 126 | 0 / 126 |
| serious Total, serious adverse events | 0 / 126 | 0 / 126 |
Outcome results
Primary
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time frame: At 1 week follow up
Population: There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LD118033 Contact Lens | Visual Acuity | 0.023 logMAR | Standard Deviation 0.078 |
| PureVision Multifocal Contact Lens | Visual Acuity | 0.005 logMAR | Standard Deviation 0.069 |
Secondary
Symptoms/Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Time frame: At 1 week follow up
Population: There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LD118033 Contact Lens | Symptoms/Complaints | Burning/stinging upon insertion | 91.3 score on a scale | Standard Deviation 12.6 |
| LD118033 Contact Lens | Symptoms/Complaints | Comfort upon insertion | 87.0 score on a scale | Standard Deviation 16.6 |
| LD118033 Contact Lens | Symptoms/Complaints | Comfort at end of day | 72.5 score on a scale | Standard Deviation 24.4 |
| LD118033 Contact Lens | Symptoms/Complaints | Overall comfort | 79.2 score on a scale | Standard Deviation 21.2 |
| LD118033 Contact Lens | Symptoms/Complaints | Dryness | 78.7 score on a scale | Standard Deviation 22.4 |
| LD118033 Contact Lens | Symptoms/Complaints | Itchiness | 89.1 score on a scale | Standard Deviation 17 |
| LD118033 Contact Lens | Symptoms/Complaints | Redness | 91.9 score on a scale | Standard Deviation 12.3 |
| LD118033 Contact Lens | Symptoms/Complaints | Distance Vision | 69.3 score on a scale | Standard Deviation 30.4 |
| LD118033 Contact Lens | Symptoms/Complaints | Vision at intermediate distance | 81.2 score on a scale | Standard Deviation 20.3 |
| LD118033 Contact Lens | Symptoms/Complaints | Vision at near distance | 76.3 score on a scale | Standard Deviation 25.7 |
| LD118033 Contact Lens | Symptoms/Complaints | Overall vision | 72.9 score on a scale | Standard Deviation 25.8 |
| LD118033 Contact Lens | Symptoms/Complaints | Ease of handling/insertion | 85.7 score on a scale | Standard Deviation 18.8 |
| LD118033 Contact Lens | Symptoms/Complaints | Ease of handling/removal | 88.5 score on a scale | Standard Deviation 17.2 |
| LD118033 Contact Lens | Symptoms/Complaints | Overall impression | 24.7 score on a scale | Standard Deviation 24 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Overall vision | 73.7 score on a scale | Standard Deviation 22.7 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Burning/stinging upon insertion | 89.2 score on a scale | Standard Deviation 16.9 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Distance Vision | 76.5 score on a scale | Standard Deviation 23.3 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Comfort upon insertion | 83.9 score on a scale | Standard Deviation 18 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Ease of handling/removal | 87.5 score on a scale | Standard Deviation 17.5 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Comfort at end of day | 68.1 score on a scale | Standard Deviation 25 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Vision at intermediate distance | 80.7 score on a scale | Standard Deviation 18.3 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Overall comfort | 74.6 score on a scale | Standard Deviation 22.9 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Ease of handling/insertion | 85.4 score on a scale | Standard Deviation 19.7 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Dryness | 75.2 score on a scale | Standard Deviation 23.7 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Vision at near distance | 72.2 score on a scale | Standard Deviation 26.2 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Itchiness | 84.5 score on a scale | Standard Deviation 21.1 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Overall impression | 74.6 score on a scale | Standard Deviation 22.7 |
| PureVision Multifocal Contact Lens | Symptoms/Complaints | Redness | 87.0 score on a scale | Standard Deviation 18 |