Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
NCT ID: NCT01699750
Last Updated: 2014-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2012-12-31
2013-11-30
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
SINGLE
Study Groups
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Air Optix Aqua
Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
Lotrafilcon B contact lenses
Silicone hydrogel contact lenses, Phase 2
OPTI-FREE® PUREMOIST® MPDS
Contact lens care system, Phase 2
BIOTRUE®
Contact lens care system, Phase 2
Balafilcon A contact lenses
Silicone hydrogel contact lenses worn for 30 days, Phase 1
ReNu® Multiplus®
Contact lens care system used for 30 days, Phase 1
Acuvue Oasys
Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Senofilcon A contact lenses
Silicone hydrogel contact lenses, Phase 2
OPTI-FREE® PUREMOIST® MPDS
Contact lens care system, Phase 2
BIOTRUE®
Contact lens care system, Phase 2
Balafilcon A contact lenses
Silicone hydrogel contact lenses worn for 30 days, Phase 1
ReNu® Multiplus®
Contact lens care system used for 30 days, Phase 1
Interventions
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Lotrafilcon B contact lenses
Silicone hydrogel contact lenses, Phase 2
Senofilcon A contact lenses
Silicone hydrogel contact lenses, Phase 2
OPTI-FREE® PUREMOIST® MPDS
Contact lens care system, Phase 2
BIOTRUE®
Contact lens care system, Phase 2
Balafilcon A contact lenses
Silicone hydrogel contact lenses worn for 30 days, Phase 1
ReNu® Multiplus®
Contact lens care system used for 30 days, Phase 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Read, sign, and date the Informed Consent;
* Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
* Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
* Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
* Best corrected visual acuity of 6/9 or better in each eye;
* Normal eyes with the exception of the need for visual correction;
Exclusion Criteria
* Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
* Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
* Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
* Systemic or ocular allergies which might interfere with contact lens wear;
* Ocular disease which might interfere with contact lens wear;
* Active ocular infection;
* Use of any concomitant topical ocular medications during the study period;
* Previous ocular surgery;
* Pregnant, planning to become pregnant, or lactating at the time of enrollment;
* Participation in an investigational drug or device study within 30 days of entering this study;
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Jami Kern, PhD
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, United States
Countries
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Other Identifiers
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M-12-043 / ID11-59
Identifier Type: -
Identifier Source: org_study_id