Presbyopia
Conditions
Brief summary
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
Interventions
Worn on a daily wear basis for one week.
DEVICEPureVision contact lens
Worn on a daily wear basis for one week
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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. * Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction. * Have no active ocular disease or allergic conjunctivitis. * Must not be using any topical ocular medications. * Must habitually use a lens care product for lens cleaning, disinfecting, and storage.
Exclusion criteria
* Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Anisometropia (spherical equivalent) of greater than 2.00 D. * Any systemic disease affecting ocular health. * Using any systemic or topical medications that will affect ocular physiology or lens performance. * Allergic to any component in the study products. * Ocular astigmatism of greater than 1.00 D in either eye. * Have had any corneal surgery (ie, refractive surgery). * Uses AMO Ultra Care as their habitual lens care regimen. * Is a toric contact lens wearer. * Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months. * An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | At 2 weeks 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 2 weeks 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 Participants received both treatment groups in this cross-over study. | 124 |
| Total | 124 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 4.9 |
| Sex: Female, Male Female | 106 Participants |
| Sex: Female, Male Male | 18 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 2 weeks follow up
Population: There were 238 eyes assessed for visual acuity for this outcome measure. Participants/eyes received both treatment groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Contact Lens | Visual Acuity | 0.079 logMAR | Standard Deviation 0.102 |
| PureVision Contact Lens | Visual Acuity | 0.090 logMAR | Standard Deviation 0.091 |
Secondary
Symptoms/Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Time frame: At 2 weeks follow up
Population: There were 238 eyes assessed for symptoms/complaints for this outcome measure. Participants/eyes received both treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Contact Lens | Symptoms/Complaints | Dryness | 80.3 score on a scale | Standard Deviation 20.3 |
| Investigational Contact Lens | Symptoms/Complaints | Itchiness | 91.9 score on a scale | Standard Deviation 13.8 |
| Investigational Contact Lens | Symptoms/Complaints | Redness | 91.4 score on a scale | Standard Deviation 14.4 |
| Investigational Contact Lens | Symptoms/Complaints | Burning/stinging upon insertion | 95.6 score on a scale | Standard Deviation 8.9 |
| Investigational Contact Lens | Symptoms/Complaints | Comfort upon insertion | 89.4 score on a scale | Standard Deviation 17 |
| Investigational Contact Lens | Symptoms/Complaints | Comfort at end of day | 75.3 score on a scale | Standard Deviation 25.4 |
| Investigational Contact Lens | Symptoms/Complaints | Overall comfort | 81.6 score on a scale | Standard Deviation 20.3 |
| Investigational Contact Lens | Symptoms/Complaints | Distance vision | 67.7 score on a scale | Standard Deviation 29.8 |
| Investigational Contact Lens | Symptoms/Complaints | Vision at intermediate distance | 80.5 score on a scale | Standard Deviation 22.5 |
| Investigational Contact Lens | Symptoms/Complaints | Vision at near distance | 65.0 score on a scale | Standard Deviation 30 |
| Investigational Contact Lens | Symptoms/Complaints | Overall vision | 66.7 score on a scale | Standard Deviation 25.4 |
| Investigational Contact Lens | Symptoms/Complaints | Ease of handling/insertion | 86.5 score on a scale | Standard Deviation 20.4 |
| Investigational Contact Lens | Symptoms/Complaints | Ease of handling/removal | 88.6 score on a scale | Standard Deviation 16.3 |
| Investigational Contact Lens | Symptoms/Complaints | Overall impression | 73.3 score on a scale | Standard Deviation 23.5 |
| PureVision Contact Lens | Symptoms/Complaints | Overall vision | 56.2 score on a scale | Standard Deviation 27.5 |
| PureVision Contact Lens | Symptoms/Complaints | Dryness | 73.3 score on a scale | Standard Deviation 26.4 |
| PureVision Contact Lens | Symptoms/Complaints | Distance vision | 59.3 score on a scale | Standard Deviation 30.8 |
| PureVision Contact Lens | Symptoms/Complaints | Itchiness | 86.8 score on a scale | Standard Deviation 22.1 |
| PureVision Contact Lens | Symptoms/Complaints | Ease of handling/removal | 86.2 score on a scale | Standard Deviation 19.6 |
| PureVision Contact Lens | Symptoms/Complaints | Redness | 86.9 score on a scale | Standard Deviation 23 |
| PureVision Contact Lens | Symptoms/Complaints | Vision at intermediate distance | 70.3 score on a scale | Standard Deviation 25.8 |
| PureVision Contact Lens | Symptoms/Complaints | Burning/stinging upon insertion | 92.5 score on a scale | Standard Deviation 14.7 |
| PureVision Contact Lens | Symptoms/Complaints | Ease of handling/insertion | 84.3 score on a scale | Standard Deviation 21.7 |
| PureVision Contact Lens | Symptoms/Complaints | Comfort upon insertion | 81.5 score on a scale | Standard Deviation 25 |
| PureVision Contact Lens | Symptoms/Complaints | Vision at near distance | 58.8 score on a scale | Standard Deviation 30.8 |
| PureVision Contact Lens | Symptoms/Complaints | Comfort at end of day | 64.9 score on a scale | Standard Deviation 28.8 |
| PureVision Contact Lens | Symptoms/Complaints | Overall impression | 61.1 score on a scale | Standard Deviation 29.9 |
| PureVision Contact Lens | Symptoms/Complaints | Overall comfort | 70.5 score on a scale | Standard Deviation 26.7 |