Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-10-17
2026-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. \- Medical grade acrylic tip covered by a sterile commercially available bandage contact lens (Air Optix, Night and Day Contacts, Alcon). The bandage contact lens will be changed between subjects and the underlying acrylic tip sterilized per standard clinical procedure (bleach soak followed by soak and rinse in sterile water).
2. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \< 100 µm. T
3. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \> 100 µm.
4. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \< 100 µm with blur tint. All tips will be sterilized between subjects
5. \- Standard tip in conjunction with a topical anesthetic
DIAGNOSTIC
NONE
Study Groups
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Medical grade acrylic tip covered by a sterile commercially available bandage contact lens
Sterile commercially available bandage contact lens
Medical grade acrylic tip covered by a sterile commercially available bandage contact lens
Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm
Medical grade silicone of a thickness <100 µm
Medical grade acrylic tip coated with medical grade silicone of a thickness \<100 µm
Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm
Medical grade silicone of a thickness >100 µm
Medical grade acrylic tip coated with medical grade silicone of a thickness \>100 µm
Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blue tint
Medical grade silicone of a thickness <100 µm with blur tint
Medical grade acrylic tip coated with medical grade silicone of a thickness \<100 µm with blur tint
Standard tip in conjunction with a topical anesthetic
Standard tip in conjunction with a topical anesthetic
Standard tip in conjunction with a topical anesthetic
Interventions
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Sterile commercially available bandage contact lens
Medical grade acrylic tip covered by a sterile commercially available bandage contact lens
Medical grade silicone of a thickness <100 µm
Medical grade acrylic tip coated with medical grade silicone of a thickness \<100 µm
Medical grade silicone of a thickness >100 µm
Medical grade acrylic tip coated with medical grade silicone of a thickness \>100 µm
Medical grade silicone of a thickness <100 µm with blur tint
Medical grade acrylic tip coated with medical grade silicone of a thickness \<100 µm with blur tint
Standard tip in conjunction with a topical anesthetic
Standard tip in conjunction with a topical anesthetic
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years of age
* Able and willing to give consent
Exclusion Criteria
* Active infection of the eye
* History of alternated corneal sensitivity
* History of corneal surgery
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Joanne Wen, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Eye Center
Locations
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Duke Eye Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Joanne Wen, MD
Role: primary
Other Identifiers
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399000397
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00115919
Identifier Type: -
Identifier Source: org_study_id