Contact Lens WearNCT04158466
A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens
A study testing Kalifilcon A Daily Disposable Contact Lenses and Biotrue ONEday Daily Disposable Contact Lenses in people with Contact Lens Wear, run by Bausch & Lomb Incorporated at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Wear
- What is being tested?
- Kalifilcon A Daily Disposable Contact Lenses and Biotrue ONEday Daily Disposable Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 16 sitesUnited States
- Study dates
- 31 May 2019to 12 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Bausch Site 4
‘Aiea, Hawaii, 96701
Bausch Site 11
Bloomington, Minnesota, 61701
Bausch Site 14
Brentwood, Tennessee, 37027
Bausch Site 16
Honolulu, Hawaii, 96814
Bausch Site 8
Los Angeles, California, 90012
Bausch Site 5
Memphis, Tennessee, 38119
Bausch Site 3
Nashville, Tennessee, 37205
Bausch Site 15
New Berlin, Wisconsin, 53151
Bausch Site 7
Pittsburg, Kansas, 66762
Bausch Site 9
San Francisco, California, 94112
Bausch Site 6
Sarasota, Florida, 34237
Bausch Site 1
St Louis, Missouri, 63144
Bausch Site 2
State College, Pennsylvania, 16801
Bausch Site 10
Torrance, California, 90503
Bausch Site 12
Torrance, California, 90505
Bausch Site 13
Vestal, New York, 13850
About this study
Official title: A Study to Evaluate the Safety and Efficacy of a Kalifilcon A Contact Lens for Daily Disposable Use
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.
Read the 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).
- Conditions
- Contact Lens Wear
- Being tested
- Kalifilcon A Daily Disposable Contact Lenses, Biotrue ONEday Daily Disposable Contact Lenses
- Keywords
- Disposable Contact Lenses, Soft Contact Lens, Soft Contact Lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kalifilcon A Daily Disposable Contact LensesDevice
Contact lens
Biotrue ONEday Daily Disposable Contact LensesDevice
Also called Bausch + Lomb Biotrue ONEday® Daily Contact Lens
Contact lens
| Study group | Role | What they receive |
|---|---|---|
| Kalifilcon A Daily Disposable Contact Lenses | Experimental | 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. Receives: Device: Kalifilcon A Daily Disposable Contact Lenses |
| Biotrue ONEday Daily Disposable Contact Lenses | Active comparator | 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. Receives: Device: Biotrue ONEday Daily Disposable Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start31 May 2019
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contact Lens WearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Donatello, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158466
- Sponsor's protocol ID
- 890
- Status last verified
- Oct 2020
- First submitted
- 7 Nov 2019
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of a Kalifilcon A Contact Lens for Daily Disposable Use
- ClinicalTrials.gov ID
- NCT04158466
- Acronym / sponsor ID
- 890
- Conditions
- Contact Lens Wear
- Keywords
- Disposable Contact Lenses, Soft Contact Lens, Soft Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kalifilcon A Daily Disposable Contact Lenses | Experimental | Device: Kalifilcon A Daily Disposable Contact LensesParticipants 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. |
| Biotrue ONEday Daily Disposable Contact Lenses | Active comparator | Device: Biotrue ONEday Daily Disposable Contact LensesParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kalifilcon A Daily Disposable Contact LensesContact lens | Device | Kalifilcon A Daily Disposable Contact Lenses |
| Biotrue ONEday Daily Disposable Contact LensesAlso: Bausch + Lomb Biotrue ONEday® Daily Contact LensContact lens | Device | Biotrue ONEday Daily Disposable Contact Lenses |
Primary outcome
Mean logMAR Contact Lens Visual Acuity
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Donatello study director
Bausch & Lomb Incorporated
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kalifilcon A Daily Disposable Contact Lenses and Biotrue ONEday Daily Disposable Contact Lenses in people with Contact Lens Wear, run by Bausch & Lomb Incorporated at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean logMAR Contact Lens Visual Acuity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.