Andre Vision and Device Research
West Linn, Oregon, 97068, United States
NCT Number: NCT03525704
Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir
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Notify Me18 year and older
All sexes
Interventional
Not applicable
West Linn, Oregon, 97068, United States
One-month, approximately 36 subjects enrolled (~12/site), randomized, double-masked crossover trial.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
•
Exclusion criteria
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
Other names: NutriFill, GatorFill
sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
Other names: LacriPure, ScleralFil
Time frame: 1 Month
Participant Survey on Lens Comfort (based on a scale of 0 to 5), Symptoms (graded based on frequency (rarely/sometimes/often/always) and severity(slight/moderate/severe)), Total Wear Time (reported as hours per day) and How Many Times Lenses are Removed Daily (reported as number of times per day)
Time frame: 1 Month
Edema, Bulbar Redness, Limbal Redness, Corneal Vascularization, Corneal Infiltrates, Palpebral Conjunctival Observations and Corneal Staining are evaluated on a grading scale of 0 to 4.
Time frame: 1 Month
Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.
Contamac Ltd
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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