Contact Lens Wear
Conditions
Keywords
Disposable Contact Lenses, Soft Contact Lens, Soft Contact Lenses
Brief summary
This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
Detailed description
Approximately 247 participants (494 eyes) will be enrolled in at approximately 20 investigative sites in the United States (US). A minimum of 20% of the randomized participants will be of Japanese descent (for example, both maternal and paternal grandparents born in Japan).
Interventions
DEVICEKalifilcon A Daily Disposable Contact Lenses
Contact lens
DEVICEBiotrue ONEday Daily Disposable Contact Lenses
Contact lens
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations. * Participants must be myopic and require lens correction from -0.25 to -6.00 Diopter (D) with 0.25 D steps, in each eye. * Participants must be correctable through spherocylindrical refraction and with soft spherical contact lenses to 40 letters (0.14 logMAR) or better (2 meters distance, high-contrast chart) in each eye. * Participants must be free of any anterior segment disorders. * Participants must be adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day at least 5 days per week on a daily disposable wear basis for approximately 3 months. * Participants must be willing and able to comply with all treatment and follow-up/study procedures, as well as willing and able to refrain from using any other contact lenses or solutions other than those provided for the duration of the study.
Exclusion criteria
* Participation in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation. * Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they are currently pregnant, plans to become pregnant during the study, or is breastfeeding * Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last 3 months. * Participants with any systemic disease currently affecting ocular health or in the Investigator's opinion may have an effect on ocular health during the course of the study. * Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Participants with an active ocular disease or who are using any ocular medication. * Participants who currently wear monovision, multifocal, or toric contact lenses. * Participants with an ocular astigmatism of greater than 1.00 D in either eye. * Participants with anisometropia (spherical equivalent) of greater than 2.00 D. * Participants with any Grade 2 or greater finding during the slit lamp examination. Participants with corneal infiltrates of any grade. * Participants with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Participants with any scar or neovascularization within the central 6 millimeters (mm) of the cornea. * Participants who are aphakic. * Participants who are amblyopic. * Participants who have had any corneal surgery (for example, refractive surgery). * Participants who are allergic to any component in the study care products. * The participant is an employee of the investigative site. * The participant, or a member of the participant's household, is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician. * The participant, or a member of the participant's household, is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Johnson & Johnson). * The participant, or a member of the participant's household, is an employee of a market research firm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean logMAR Contact Lens Visual Acuity | 3 months | Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits. |
| Proportion of Participants With Slit Lamp Findings Greater Than Grade 2 | 3 months | During an examination of both eyes without lenses, graded slit lamp findings will be assessed for each eye using Grades 0 (none), 1 (trace), 2 (mild), 3 (moderate), and 4 (severe). Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than Grade 2 at any visit (Absent or Present). Epithelial edema, epithelial microcysts, corneal staining, limbal Injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be evaluated. |
Countries
United States
Participant flow
Recruitment details
There were 252 participants randomized but 251 participants received treatment. Participants are summarized by actual treatment group received.
Participants by arm
| Arm | Count |
|---|---|
| Kalifilcon A Daily Disposable Contact Lenses Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.
Kalifilcon A Daily Disposable Contact Lenses: Contact lens | 124 |
| Biotrue ONEday Daily Disposable Contact Lenses Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.
Biotrue ONEday Daily Disposable Contact Lenses: Contact lens | 127 |
| Total | 251 |
Baseline characteristics
| Characteristic | Kalifilcon A Daily Disposable Contact Lenses | Biotrue ONEday Daily Disposable Contact Lenses | Total |
|---|---|---|---|
| Age, Continuous | 35.9 years | 33.6 years | 34.7 years |
| Average Daily Wear Time | 13.5 hours per day | 13.4 hours per day | 13.4 hours per day |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 60 Participants | 55 Participants | 115 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 64 Participants | 123 Participants |
| Sex: Female, Male Female | 88 Participants | 94 Participants | 182 Participants |
| Sex: Female, Male Male | 36 Participants | 33 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 127 |
| other Total, other adverse events | 0 / 124 | 0 / 127 |
| serious Total, serious adverse events | 0 / 124 | 0 / 127 |
Outcome results
Primary
Mean logMAR Contact Lens Visual Acuity
Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits.
Time frame: 3 months
Population: The per protocol population consisted of randomized without important (major) protocol deviations. It is a subset of the participants randomized and treated.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Kalifilcon A Daily Disposable Contact Lenses | Mean logMAR Contact Lens Visual Acuity | -0.066 units on a scale | Standard Error 0.0034 |
| Biotrue ONEday Daily Disposable Contact Lenses | Mean logMAR Contact Lens Visual Acuity | -0.060 units on a scale | Standard Error 0.0032 |
Primary
Proportion of Participants With Slit Lamp Findings Greater Than Grade 2
During an examination of both eyes without lenses, graded slit lamp findings will be assessed for each eye using Grades 0 (none), 1 (trace), 2 (mild), 3 (moderate), and 4 (severe). Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than Grade 2 at any visit (Absent or Present). Epithelial edema, epithelial microcysts, corneal staining, limbal Injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be evaluated.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Kalifilcon A Daily Disposable Contact Lenses | Proportion of Participants With Slit Lamp Findings Greater Than Grade 2 | 0 eyes |
| Biotrue ONEday Daily Disposable Contact Lenses | Proportion of Participants With Slit Lamp Findings Greater Than Grade 2 | 0 eyes |