Myopia
Conditions
Brief summary
The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.
Interventions
DEVICEPureVision Contact Lens
contact lens for daily wear
contact lens for daily wear
DEVICEO2Optix Contact lens
contact lens for daily wear
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is myopic * VA correctable to 0.3 LogMAR or better (driving vision) * Clear central cornea * Subject uses a lens care system on a regular basis
Exclusion criteria
* Systemic disease affecting ocular health * Using systemic or topical medications * Wear monovision, multifocal or toric contact lenses * Any grade 2 or greater slit lamp findings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any Slit Lamp Finding > Grade 2 | Over all follow-up visits for the 1 month study period | All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured. |
| Subjective Responses to Comfort-related Symptoms/Complaints | Over all follow-up visits for 1 month study period | Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating. |
| Uncorrected Distance High Contrast Visual Acuity | Over all visits for the 1 month study period | logMAR high contrast visual acuity (VA) over all visits. |
Countries
United States
Participant flow
Recruitment details
546 subjects (1092 eyes) were planned to be enrolled at 26 investigative sites in the US. First subject enrolled on 2/25/2008 and last subject seen was 4/28/2008.
Pre-assignment details
510 subjects (1020 eyes) were enrolled (all were dispensed). 477 subjects (954 eyes) completed the study. 10 subjects were ineligible at baseline and 23 were discontinued during the study.
Participants by arm
| Arm | Count |
|---|---|
| PureVision Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis. | 165 |
| Acuvue Oasys Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis. | 167 |
| O2Optix Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis. | 168 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Adverse event and positive slit lamp | 1 | 0 | 0 |
| Overall Study | Failure to Follow Subject Instructions | 1 | 0 | 0 |
| Overall Study | Inability to Maintain Wearing Schedule | 1 | 1 | 0 |
| Overall Study | Ineligable at Baseline | 5 | 3 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 |
| Overall Study | Poor fit/Uncomfortable | 4 | 0 | 0 |
| Overall Study | Positive Slit Lamp Findings | 0 | 0 | 1 |
| Overall Study | Study Related Symptoms/Complaints | 2 | 1 | 2 |
| Overall Study | Unacceptable Lens Movement | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 1 |
Baseline characteristics
| Characteristic | PureVision | Acuvue Oasys | O2Optix | Total |
|---|---|---|---|---|
| Age, Customized Age 18 to 65 years | 165 Participants | 167 Participants | 168 Participants | 500 Participants |
| Region of Enrollment United States | 165 Participants | 167 Participants | 168 Participants | 500 Participants |
| Sex: Female, Male Female | 125 Participants | 127 Participants | 124 Participants | 376 Participants |
| Sex: Female, Male Male | 40 Participants | 40 Participants | 44 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 340 | 0 / 340 | 0 / 340 |
| serious Total, serious adverse events | 0 / 340 | 0 / 340 | 0 / 340 |
Outcome results
Primary
Any Slit Lamp Finding > Grade 2
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.
Time frame: Over all follow-up visits for the 1 month study period
Population: All dispensed eyes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PureVision | Any Slit Lamp Finding > Grade 2 | 2 Eyes |
| Acuvue Oasys | Any Slit Lamp Finding > Grade 2 | 5 Eyes |
| O2Optix | Any Slit Lamp Finding > Grade 2 | 10 Eyes |
Primary
Subjective Responses to Comfort-related Symptoms/Complaints
Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
Time frame: Over all follow-up visits for 1 month study period
Population: All eligible dispensed eyes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureVision | Subjective Responses to Comfort-related Symptoms/Complaints | End of Day Comfort | 76.1 Units on a Scale | Standard Deviation 21.86 |
| PureVision | Subjective Responses to Comfort-related Symptoms/Complaints | Redness | 91.0 Units on a Scale | Standard Deviation 14.93 |
| PureVision | Subjective Responses to Comfort-related Symptoms/Complaints | Irritation | 81.7 Units on a Scale | Standard Deviation 20.15 |
| PureVision | Subjective Responses to Comfort-related Symptoms/Complaints | Lens Awareness | 79.9 Units on a Scale | Standard Deviation 23.46 |
| PureVision | Subjective Responses to Comfort-related Symptoms/Complaints | Dryness | 81.9 Units on a Scale | Standard Deviation 20.22 |
| PureVision | Subjective Responses to Comfort-related Symptoms/Complaints | Comfort Throughout the Day | 82.9 Units on a Scale | Standard Deviation 18.94 |
| PureVision | Subjective Responses to Comfort-related Symptoms/Complaints | Morning Comfort | 85.5 Units on a Scale | Standard Deviation 17.55 |
| PureVision | Subjective Responses to Comfort-related Symptoms/Complaints | Itching | 89.9 Units on a Scale | Standard Deviation 15.75 |
| Acuvue Oasys | Subjective Responses to Comfort-related Symptoms/Complaints | Lens Awareness | 89.5 Units on a Scale | Standard Deviation 16.3 |
| Acuvue Oasys | Subjective Responses to Comfort-related Symptoms/Complaints | Morning Comfort | 92.9 Units on a Scale | Standard Deviation 11.97 |
| Acuvue Oasys | Subjective Responses to Comfort-related Symptoms/Complaints | Comfort Throughout the Day | 90.1 Units on a Scale | Standard Deviation 14.47 |
| Acuvue Oasys | Subjective Responses to Comfort-related Symptoms/Complaints | End of Day Comfort | 85.2 Units on a Scale | Standard Deviation 16.69 |
| Acuvue Oasys | Subjective Responses to Comfort-related Symptoms/Complaints | Irritation | 90.5 Units on a Scale | Standard Deviation 14.42 |
| Acuvue Oasys | Subjective Responses to Comfort-related Symptoms/Complaints | Itching | 93.5 Units on a Scale | Standard Deviation 12.81 |
| Acuvue Oasys | Subjective Responses to Comfort-related Symptoms/Complaints | Dryness | 89.1 Units on a Scale | Standard Deviation 14.42 |
| Acuvue Oasys | Subjective Responses to Comfort-related Symptoms/Complaints | Redness | 94.5 Units on a Scale | Standard Deviation 11.14 |
| O2Optix | Subjective Responses to Comfort-related Symptoms/Complaints | Lens Awareness | 86.4 Units on a Scale | Standard Deviation 17.91 |
| O2Optix | Subjective Responses to Comfort-related Symptoms/Complaints | Itching | 92.2 Units on a Scale | Standard Deviation 13.57 |
| O2Optix | Subjective Responses to Comfort-related Symptoms/Complaints | Morning Comfort | 92.0 Units on a Scale | Standard Deviation 12.79 |
| O2Optix | Subjective Responses to Comfort-related Symptoms/Complaints | Redness | 91.9 Units on a Scale | Standard Deviation 14.23 |
| O2Optix | Subjective Responses to Comfort-related Symptoms/Complaints | End of Day Comfort | 81.4 Units on a Scale | Standard Deviation 18.4 |
| O2Optix | Subjective Responses to Comfort-related Symptoms/Complaints | Dryness | 85.0 Units on a Scale | Standard Deviation 17.46 |
| O2Optix | Subjective Responses to Comfort-related Symptoms/Complaints | Irritation | 87.0 Units on a Scale | Standard Deviation 15.89 |
| O2Optix | Subjective Responses to Comfort-related Symptoms/Complaints | Comfort Throughout the Day | 88.4 Units on a Scale | Standard Deviation 13.43 |
Primary
Uncorrected Distance High Contrast Visual Acuity
logMAR high contrast visual acuity (VA) over all visits.
Time frame: Over all visits for the 1 month study period
Population: All eligible dispensed eyes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PureVision | Uncorrected Distance High Contrast Visual Acuity | -0.031 LogMAR | Standard Deviation 0.07 |
| Acuvue Oasys | Uncorrected Distance High Contrast Visual Acuity | -0.026 LogMAR | Standard Deviation 0.071 |
| O2Optix | Uncorrected Distance High Contrast Visual Acuity | -0.024 LogMAR | Standard Deviation 0.076 |