Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
Andre Vision and Device Research
West Linn, Oregon, United States
Patient Subjective Symptoms and Wear Time Survey
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
Biomicroscopy Findings
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
Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.
Time frame: 1 Month
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