Evaluation of Safety and Tolerability of Ocular Lubricants
NCT ID: NCT05573360
Last Updated: 2023-07-06
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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COMPLETED
NA
41 participants
INTERVENTIONAL
2022-12-16
2023-05-31
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
NONE
Study Groups
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Sequence 1
NGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation
NGF5-A test formulation
One drop of investigational product instilled on the eye
NGF4-B test formulation
One drop of investigational product instilled on the eye
NGF6-B test formulation
One drop of investigational product instilled on the eye
NGF6-E test formulation
One drop of investigational product instilled on the eye
Systane eye drop
One drop of commercial product instilled on the eye
Sequence 2
NGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation
NGF5-A test formulation
One drop of investigational product instilled on the eye
NGF4-B test formulation
One drop of investigational product instilled on the eye
NGF6-B test formulation
One drop of investigational product instilled on the eye
NGF6-E test formulation
One drop of investigational product instilled on the eye
Systane eye drop
One drop of commercial product instilled on the eye
Sequence 3
NGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation
NGF5-A test formulation
One drop of investigational product instilled on the eye
NGF4-B test formulation
One drop of investigational product instilled on the eye
NGF6-B test formulation
One drop of investigational product instilled on the eye
NGF6-E test formulation
One drop of investigational product instilled on the eye
Systane eye drop
One drop of commercial product instilled on the eye
Sequence 4
NGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation
NGF5-A test formulation
One drop of investigational product instilled on the eye
NGF4-B test formulation
One drop of investigational product instilled on the eye
NGF6-B test formulation
One drop of investigational product instilled on the eye
NGF6-E test formulation
One drop of investigational product instilled on the eye
Systane eye drop
One drop of commercial product instilled on the eye
Sequence 5
Systane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation
NGF5-A test formulation
One drop of investigational product instilled on the eye
NGF4-B test formulation
One drop of investigational product instilled on the eye
NGF6-B test formulation
One drop of investigational product instilled on the eye
NGF6-E test formulation
One drop of investigational product instilled on the eye
Systane eye drop
One drop of commercial product instilled on the eye
Interventions
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NGF5-A test formulation
One drop of investigational product instilled on the eye
NGF4-B test formulation
One drop of investigational product instilled on the eye
NGF6-B test formulation
One drop of investigational product instilled on the eye
NGF6-E test formulation
One drop of investigational product instilled on the eye
Systane eye drop
One drop of commercial product instilled on the eye
Eligibility Criteria
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Inclusion Criteria
* Willing and able to attend all study visits as required by the protocol.
Exclusion Criteria
* Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
* Any ocular injury to either eye in the past 12 weeks prior to screening.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Lead, Dry Eye
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Alcon Investigator 8169
Carlton, Victoria, Australia
Alcon Investigator 8214
Waurn Ponds, Victoria, Australia
Countries
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Other Identifiers
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DEE253-E001
Identifier Type: -
Identifier Source: org_study_id
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