Clinical Biocompatibility Evaluation of Contact Lens Coatings
NCT ID: NCT03034928
Last Updated: 2020-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2017-02-14
2017-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Test 1/Control 1, then Control 2/Test 2
Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Contact lens with investigational coating 1
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lens
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
Contact lens with investigational coating 2
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
Test 2/Control 2, then Control 1/Test 1
Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Contact lens with investigational coating 1
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lens
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
Contact lens with investigational coating 2
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
Control 1/Test 1, then Test 2/Control 2
Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Contact lens with investigational coating 1
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lens
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
Contact lens with investigational coating 2
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
Control 2/Test 2, then Test 1/Control 1
Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Contact lens with investigational coating 1
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lens
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
Contact lens with investigational coating 2
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
Interventions
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Contact lens with investigational coating 1
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lens
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
Contact lens with investigational coating 2
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;
* Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
* VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;
Exclusion Criteria
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
* Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Current or history of pathologically dry eye in either eye that would preclude contact lens wear;
* Current or history of herpetic keratitis in either eye;
* Eye injury in either eye within 12 weeks immediately prior to enrollment;
* History of intolerance or hypersensitivity to any component of the study lenses or solutions;
* Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Clinical Manager, Trial Management Operations
Role: STUDY_DIRECTOR
Alcon, A Novartis Division
Locations
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Alcon Investigative Site
Johns Creek, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLY935-E002
Identifier Type: -
Identifier Source: org_study_id
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