A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses
NCT ID: NCT03897751
Last Updated: 2023-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
252 participants
INTERVENTIONAL
2019-03-08
2019-08-01
Brief Summary
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Detailed Description
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* Etaficon A, Acuvue2, Vistakon
* Balafilcon A, PureVision2, Bausch + Lomb
* Samfilcon A, Ultra, Bausch + Lomb
* Lotrafilcon B, Optix Aqua, Alcon
* Senofilcon C, Vita, Vistakon
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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ABT12 Multi-Purpose Solution
Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.
ABT12 Multi-Purpose Solution
Contact lens cleaning and disinfecting solution
Sensitive Eyes® Rewetting Drops
For use as needed during the study.
COMPLETE Multi-Purpose Solution
Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.
COMPLETE Multi-Purpose Solution
Contact lens cleaning and disinfecting solution
Sensitive Eyes® Rewetting Drops
For use as needed during the study.
Interventions
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ABT12 Multi-Purpose Solution
Contact lens cleaning and disinfecting solution
COMPLETE Multi-Purpose Solution
Contact lens cleaning and disinfecting solution
Sensitive Eyes® Rewetting Drops
For use as needed during the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is a habitual wearer (at least 3 months) of one of the following lens types: 1) Etaficon A, Acuvue2, Vistakon; 2) Balafilcon A, PureVision2, Bausch + Lomb; 3) Samfilcon A, Ultra, Bausch + Lomb; 4) Lotrafilcon B, Optix Aqua, Alcon; 5) Senofilcon C, Vita, Vistakon
* Vision is correctable through spherocylindrical refraction to 32 letters (0.3 logarithm of the minimum angle of resolution \[logMAR\]) or better (distance, high contrast) in each eye with soft spherical contact lenses
* Has clear central corneas and is free of any anterior segment disorders
* Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses
* Requires lens correction in both eyes
* Wears the same manufacturer and brand of lens in both eyes
* Agrees to wear study lenses on a daily wear basis for approximately 3 months
* Is willing and able to comply with all treatment and follow-up/study procedures
Exclusion Criteria
* Participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation
* Females of childbearing potential (those who are not surgically sterilized or postmenopausal), if they are currently pregnant, plan to become pregnant during the study, or are breastfeeding
* Has worn gas permeable (GP) lenses within the last 30 days.
* Has worn polymethylmethacrylate (PMMA) lenses within the last 3 months
* Has 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
* Has any ocular disease or is using any ocular medication
* Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance
* Currently wears monovision, multifocal, or toric contact lenses
* Has ocular astigmatism of 1.00 diopter (D) or greater in either eye
* Vision is not correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses
* Has anisometropia (spherical equivalent) of greater than 2.00D
* Has any Grade 2 or greater finding during the slit lamp examination
* Has 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
* Has any scar or neovascularization within the central 6 millimeters (mm) of the cornea. Note that participants with minor peripheral corneal scarring (that does not extend into the central area), that, in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study
* Is aphakic
* Is amblyopic
* Has had any corneal surgery (for example, refractive surgery)
* Is allergic to any component in the study care products
* Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee's household
* Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties
* Is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, or Johnson \& Johnson) or currently resides with a person employed by any of these manufacturers
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson Varughese
Role: STUDY_DIRECTOR
Bausch & Lomb Incorporated
Locations
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Bausch Site 1
Birmingham, Alabama, United States
Bausch Site 2
San Diego, California, United States
Bausch Site 3
San Francisco, California, United States
Bausch Site 4
Denver, Colorado, United States
Bausch Site 5
Sarasota, Florida, United States
Bausch Site 6
Decatur, Georgia, United States
Bausch Site 7
Bloomington, Illinois, United States
Bausch Site 9
Leavenworth, Kansas, United States
Bausch Site 8
Pittsburg, Kansas, United States
Bausch Site 10
Portland, Maine, United States
Bausch Site 11
East Lansing, Michigan, United States
Bausch Site 12
St Louis, Missouri, United States
Bausch Site 13
Jamestown, New York, United States
Bausch Site 14
Vestal, New York, United States
Bausch Site 15
State College, Pennsylvania, United States
Bausch Site 17
Brentwood, Tennessee, United States
Bausch Site 16
Nashville, Tennessee, United States
Countries
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References
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Schaeffer M, Shahidi A, Mosehauer G, Rah M, Reindel W. Clinical Evaluation of Biotrue Hydration Plus Multipurpose Solution in Daily Use with Planned Replacement Soft Contact Lenses. Ophthalmol Ther. 2025 Jun;14(6):1249-1260. doi: 10.1007/s40123-025-01123-0. Epub 2025 Apr 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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932
Identifier Type: -
Identifier Source: org_study_id
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