Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging

Conditions
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Contact Lens Complication, Debris in Post Lens Tear Reservoir

Intervention / Treatment
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* Device: Saline Solution Enriched
* Device: Saline Rinse Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• Daily wear large diameter (scleral) rigid gas permeable contact lens wearers in design with acceptable fit 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: Extended wear contact lens wearers 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: One-month, approximately 36 subjects enrolled ( 12/site), randomized, double-masked crossover trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saline Solution Enriched<br>Saline Solution enriched with electrolytes and PH balanced to mimic normal tears | Device: Saline Solution Enriched<br>* Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution<br>* Other names: GatorFill;|
| Active Comparator: Saline Rinse Solution<br>Saline Solution .9% NaCL | Device: Saline Rinse Solution<br>* sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i<br>* Other names: ScleralFil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses. | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lenses, Fogging, Insertion Solutions, RGP, Scleral