BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
NCT ID: NCT02537730
Last Updated: 2020-08-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
33 participants
INTERVENTIONAL
2015-09-30
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
NCT02196766
The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
NCT02510820
A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
NCT00772707
Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens
NCT01294917
A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
NCT00982046
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bioclean MPS VII / comfilcon A combination
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A
contact lens
Aosept Clearcare / comfilcon A combination
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare
Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A
contact lens
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bioclean MPS VII
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
Aosept Clearcare
Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A
contact lens
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has had a self-reported visual exam in the last two years
* Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
* Has less than 1.00 D spectacle cylinder in each eye
* Is correctable to a visual acuity of 20/20 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the informed consent letter
* Is willing to comply with the wear schedule (at least 40hrs per week)
* Is willing to comply with the visit schedule
Exclusion Criteria
* Currently wears rigid gas permeable contact lens
* Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; \> 8 hours per day)
* Has a CL prescription outside the range of -0.25D to -12.00D
* Has a spectacle cylinder greater than -0.75D of cylinder in either eye
* Has best corrected spectacle distant vision worse than 20/20 in ether eye
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or sever insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars
* Is aphakic
* Is pregnant or lactating
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CooperVision, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yuji Kodama, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kodama Eye Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kodama Eye Clinic
Joyo-shi, Kyoto, Japan
Higashihara Eye Clinic
Kameoka, Kyoto, Japan
Iwasaki Eye Clinic
Osaka, Osaka, Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CVJ-EX-MKTG-1318
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.