Myopia
Conditions
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.
Detailed description
Approximately 816 participants (1,632 eyes) will be enrolled in this 12-month randomized, parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the US. At the Screening/Dispensing Visit, approximately one-half of the participants will be randomized to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test) and approximately one-half of the subjects will be randomized to receive Bausch + Lomb PureVision soft contact lenses (Control). Both groups will wear the assigned lenses bilaterally on a 7-day extended wear basis throughout the 12 month study. The lenses are to be worn overnight for up to six consecutive nights per week. The lenses are to be removed, cleaned and disinfected on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses at the beginning of each month. Lenses will be provided at the Screening/Dispensing, 3-Month, 6-Month and 9-Month Follow-Up visits to maintain a monthly replacement schedule. Participants will also be required to complete a paper diary.
Interventions
DEVICEBausch + Lomb Samfilcon A Soft Contact Lens
soft contact lenses
DEVICEBausch + Lomb Pure Vision Soft Contact Lens
soft contact lenses
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye. * Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand. * Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye. * Participants must have clear central corneas and be free of any anterior segment disorders. * Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.
Exclusion criteria
* Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months. * Participants with an active ocular disease or who are using any ocular medication. * Participants 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. * Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses. * Participants who currently wear monovision, multifocal, or toric contact lenses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast Visual Acuity | Month 12 | For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters). |
| Number of Participants With Adverse Events | Baseline up to Month 12 | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section. |
Countries
United States
Participant flow
Pre-assignment details
A total of 1632 eyes from 816 study participants were enrolled, of which 1612 eyes from 806 study participants were randomized into 1:1 to wear either the Bausch + Lomb samfilcon A soft contact lens or Bausch + Lomb pure vision soft contact lens.
Participants by arm
| Arm | Count |
|---|---|
| Bausch + Lomb Samfilcon A Soft Contact Lens Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. | 403 |
| Bausch + Lomb Samfilcon A Soft Contact Lens Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. | 806 |
| Bausch + Lomb Pure Vision Soft Contact Lens Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. | 402 |
| Bausch + Lomb Pure Vision Soft Contact Lens Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. | 804 |
| Total | 2,415 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 3 |
| Overall Study | Chalazion upper lid | 0 | 1 |
| Overall Study | Ineligible at Baseline | 2 | 8 |
| Overall Study | Lack of motivation | 0 | 2 |
| Overall Study | Lost to Follow-up | 13 | 16 |
| Overall Study | Military orders | 1 | 0 |
| Overall Study | Participant Relocated | 5 | 3 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Positive slit lamp findings | 0 | 1 |
| Overall Study | Pregnancy | 6 | 7 |
| Overall Study | Protocol Violation | 6 | 3 |
| Overall Study | Randomized, not dispensed | 1 | 0 |
| Overall Study | Study related symptoms | 8 | 8 |
| Overall Study | Unacceptable distance lens visual acuity | 1 | 1 |
| Overall Study | Unacceptable lens movement | 2 | 0 |
| Overall Study | Withdrawal by Subject | 12 | 28 |
Baseline characteristics
| Characteristic | Bausch + Lomb Samfilcon A Soft Contact Lens | Bausch + Lomb Pure Vision Soft Contact Lens | Total |
|---|---|---|---|
| Age, Continuous | 29.8 years STANDARD_DEVIATION 6.2 | 29.2 years STANDARD_DEVIATION 6.1 | 29.5 years STANDARD_DEVIATION 6.2 |
| Sex: Female, Male Female | 263 Participants | 265 Participants | 528 Participants |
| Sex: Female, Male Male | 140 Participants | 137 Participants | 277 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 405 | 0 / 410 |
| other Total, other adverse events | 22 / 405 | 14 / 410 |
| serious Total, serious adverse events | 0 / 405 | 0 / 410 |
Outcome results
Primary
High Contrast Visual Acuity
For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).
Time frame: Month 12
Population: Analysis set included all eligible dispensed participants under the treatment they actually received. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bausch + Lomb Samfilcon A Soft Contact Lens | High Contrast Visual Acuity | -0.065 logMAR | Standard Deviation 0.067 |
| Bausch + Lomb Pure Vision Soft Contact Lens | High Contrast Visual Acuity | -0.047 logMAR | Standard Deviation 0.071 |
Primary
Number of Participants With Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.
Time frame: Baseline up to Month 12
Population: Safety analysis set included all dispensed participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bausch + Lomb Samfilcon A Soft Contact Lens | Number of Participants With Adverse Events | 22 Participants |
| Bausch + Lomb Pure Vision Soft Contact Lens | Number of Participants With Adverse Events | 14 Participants |