A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens
NCT ID: NCT04158466
Last Updated: 2020-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
252 participants
INTERVENTIONAL
2019-05-31
2019-11-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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
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
Interventions
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Kalifilcon A Daily Disposable Contact Lenses
Contact lens
Biotrue ONEday Daily Disposable Contact Lenses
Contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Donatello
Role: STUDY_DIRECTOR
Bausch & Lomb Incorporated
Locations
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Bausch Site 8
Los Angeles, California, United States
Bausch Site 9
San Francisco, California, United States
Bausch Site 10
Torrance, California, United States
Bausch Site 12
Torrance, California, United States
Bausch Site 6
Sarasota, Florida, United States
Bausch Site 16
Honolulu, Hawaii, United States
Bausch Site 4
‘Aiea, Hawaii, United States
Bausch Site 7
Pittsburg, Kansas, United States
Bausch Site 11
Bloomington, Minnesota, United States
Bausch Site 1
St Louis, Missouri, United States
Bausch Site 13
Vestal, New York, United States
Bausch Site 2
State College, Pennsylvania, United States
Bausch Site 14
Brentwood, Tennessee, United States
Bausch Site 5
Memphis, Tennessee, United States
Bausch Site 3
Nashville, Tennessee, United States
Bausch Site 15
New Berlin, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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890
Identifier Type: -
Identifier Source: org_study_id