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| Name | Class |
|---|---|
| Andre Vision and Device Research | UNKNOWN |
| The Contact Lens Center at Optique | UNKNOWN |
| Premiere Vision Group | UNKNOWN |
| Havasu Eye Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Solution Enriched | Experimental | Saline Solution enriched with electrolytes and PH balanced to mimic normal tears |
|
| Saline Rinse Solution | Active Comparator | Saline Solution .9% NaCL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline Solution Enriched | Device | Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 Month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Month |
| Visual Acuity |
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Inclusion Criteria:•
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bret Andre, MS, ABOe | AVD Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andre Vision and Device Research | West Linn | Oregon | 97068 | United States |
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| UNKNOWN |
One-month, approximately 36 subjects enrolled (~12/site), randomized, double-masked crossover trial.
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Randomized, Double-Masked
| Saline Rinse Solution | Device | sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i |
|
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Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.
| 1 Month |