On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
NCT ID: NCT03881670
Last Updated: 2020-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
24 participants
INTERVENTIONAL
2018-12-07
2019-02-08
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
QUADRUPLE
Study Groups
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Lotrafilcon B
Lotrafilcon B
commercially available contact lens
lotrafilcon B with Hydraluxe
commercially available contact lens
Lotrafilcon B Hydraluxe
Lotrafilcon B
commercially available contact lens
lotrafilcon B with Hydraluxe
commercially available contact lens
Interventions
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Lotrafilcon B
commercially available contact lens
lotrafilcon B with Hydraluxe
commercially available contact lens
Eligibility Criteria
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Inclusion Criteria
* 18-35 years of age
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* Vertex corrected refractive cylinder must be -0.75 or less.
* Visual acuity best correctable to 20/25 or better for each eye
* The subject must read and sign the Informed Consent form.
* Mesopic pupil size \>5.00 mm.
Exclusion Criteria
* history of issues of eye alignment or binocularity by self-report
* doctor diagnosed, self-reported accommodative or binocular vision issues
* doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
18 Years
35 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
Indiana University
OTHER
Responsible Party
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Pete Kollbaum, OD, PhD
Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research
Locations
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Indiana University Clinical Optics Research Lab
Bloomington, Indiana, 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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Kollbaum002
Identifier Type: -
Identifier Source: org_study_id
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