Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
NCT ID: NCT03525704
Last Updated: 2021-01-27
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
36 participants
INTERVENTIONAL
2018-04-09
2018-12-15
Brief Summary
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Detailed Description
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Existing scleral rigid gas permeable (RGP) contact lens wearing subjects are randomly assigned (block) to different arms of the trial and receive different saline solutions for use sequentially for 2-week periods. The subjects will continue to wear their existing scleral GP lenses if lens fit is acceptable following an initial evaluation. Subjects will agree to complete a survey administered daily (via email) that will address contact lens wear time and subjective symptoms.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Saline Solution Enriched
Saline Solution enriched with electrolytes and PH balanced to mimic normal tears
Saline Solution Enriched
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
Saline Rinse Solution
Saline Solution .9% NaCL
Saline Rinse Solution
sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
Interventions
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Saline Solution Enriched
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
Saline Rinse Solution
sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years old or above.
* Agree to and sign Informed Consent.
* Correctable to at least 20/40 distance visual acuity in each eye.
* Presence of debris or "fogging" in post lens tear film reservoir (PLTR).
Exclusion Criteria
* Require concurrent ocular medication.
* Grade 2 or more slit lamp findings (does not include fogging assessment).
* Eye injury or surgery within twelve weeks immediately prior to enrolment for this trial.
* Currently enrolled in an ophthalmic clinical trial.
* Pregnant or lactating
* Evidence of active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
18 Years
ALL
Yes
Sponsors
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Andre Vision and Device Research
UNKNOWN
The Contact Lens Center at Optique
UNKNOWN
Premiere Vision Group
UNKNOWN
Havasu Eye Center
UNKNOWN
Contamac Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Bret Andre, MS, ABOe
Role: STUDY_DIRECTOR
AVD Research
Locations
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Andre Vision and Device Research
West Linn, Oregon, United States
Countries
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Other Identifiers
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AVDR 2018-01 v1.2
Identifier Type: -
Identifier Source: org_study_id
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