Myopia
Conditions
Keywords
contact lens
Brief summary
This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
Interventions
DEVICETest, daily disposable contact lens
Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
DEVICESofLens daily disposable contact lens
Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye. * Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye. * Subjects must be free of any anterior segment disorders. * Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.
Exclusion criteria
* Subjects 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. * Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Subjects who have had any corneal surgery (eg, refractive surgery). * Subjects who are allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings > Grade 2 | 4 visits over 3 months | Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses |
| High Contrast, Distance logMAR Visual Acuity (VA) | 4 visits over 3 months | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint |
Countries
United States
Participant flow
Recruitment details
A total of 173 participants (346 eyes) were enrolled at 11 investigative sites in the United States (US), the first participant was enrolled in the study on 6/13/2011, the last participant exited the study on 10/1/2011.
Pre-assignment details
This was a 3 month randomized, parallel, bilateral, single-masked study. One participant discontinued the study.
Participants by arm
| Arm | Count |
|---|---|
| SofLens The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | 86 |
| Test Lens Test contact lens will be worn on a daily disposable wear basis.
Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | 87 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study related symptoms and complaints | 1 | 0 |
Baseline characteristics
| Characteristic | SofLens | Test Lens | Total |
|---|---|---|---|
| Age, Customized Between 18 and 40 years | 86 participants | 87 participants | 173 participants |
| Region of Enrollment United States | 86 participants | 87 participants | 173 participants |
| Sex: Female, Male Female | 64 Participants | 56 Participants | 120 Participants |
| Sex: Female, Male Male | 22 Participants | 31 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 86 | 0 / 87 |
| serious Total, serious adverse events | 0 / 86 | 0 / 87 |
Outcome results
Primary
High Contrast, Distance logMAR Visual Acuity (VA)
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint
Time frame: 4 visits over 3 months
Population: All Eligible, Dispensed Eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SofLens Lens | High Contrast, Distance logMAR Visual Acuity (VA) | -0.028 logMAR | Standard Deviation 0.04 |
| Test Lens | High Contrast, Distance logMAR Visual Acuity (VA) | -0.025 logMAR | Standard Deviation 0.04 |
Primary
Slit Lamp Findings > Grade 2
Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses
Time frame: 4 visits over 3 months
Population: Over All Follow-up Visits, Eyes with Findings \> Grade 2 (All Dispensed Eyes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SofLens Lens | Slit Lamp Findings > Grade 2 | 0 eyes |
| Test Lens | Slit Lamp Findings > Grade 2 | 1 eyes |