Scleral Contact Lens Insertion Solution Study

Study Overview
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Brief Summary
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The purpose of this study is to determine the clinical ocular compatibility (feasibility of safety and efficacy) of a patented solution (US Patent 2,259,437, Stone) which contains multiple essential ions and has a pH and tonicity which more closely mimics human tears as compared to the subjects' current habitual scleral lens insertion solution.

Detailed Description
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The sterile solution is provided by prescription for each patient by a local compounding pharmacy in unit dose containers. The initial exposure - filling the posterior bowl of the scleral contact lens by the Investigator and applying the lens to the eye - will be monitored in the office for one hour, prior to any dispensing of the solution to the patient for their use at home or work. This is a one week, unmasked comparison of the new solution to the subject's habitual solution used for scleral lens insertion. The (historical) control is the saline habitually used by the subjects. The sample size is determined to be manageable to insure close supervision of the subjects in these initial trials and to inform us for future safety and efficacy trials. The primary safety outcome measure will be slit lamp examination of the ocular anterior segment and the secondary outcome measure will be photo-documentation by ocular coherence tomography of the clouding of the tears between the cornea and scleral contact lens. The primary efficacy outcome will be ocular comfort as assessed by questionnaire.

Official Title
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Scleral Contact Lens Insertion Solution Study

Conditions
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Irregular; Contour of Cornea

Intervention / Treatment
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* Device: contact lens insertion solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older. Wear a scleral contact lens habitually 6 or more hours a day. Needs to remove scleral lens due to fogging and refill or definitely reports fogging. Must have worn habitual scleral lens for at least 3 months Willing and able to attend study visits. Exclusion Criteria: Currently under treatment for an eye infection or inflammation such as adapted keratoconus or healed post penetrating keratoplasty. Stable keratoconus is acceptable. Currently taking topical ophthalmic prescription medications. Current medical eye complications such as glaucoma or uveitis. Recent corneal surgery Sjogrens or other clinically significant active ocular surface disease.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Feasibility<br>Scleral lens insertion solution study. This is not an interventional study, but a study to test a new contact lens solution. Primary FDA Classification: 21 CFR 886.5928 Soft (Hydrophilic) Contact Lens Care Products Product Code: LPN Secondary FDA Classification: 21 CFR 886.5918 - Rigid gas permeable contact lens care products Product Code: MRC The FDA has previously made risk determinations (class II, non-significant risk) for devices classified under 21 CFR 886.5928 and 21 CFR 886.5918. As a non-significant risk device, the GatorFil Contact Lens Saline Solution is exempt from the IDE regulation (21 CFR 812). | Device: contact lens insertion solution<br>* This contact lens solution is being tested for safety and comfort and is not an intervention. Subjects will have their scleral contact lenses filled with the test saline in the examination room and applied to their eyes. They will be monitored for symptoms and will be examined. Six to 8 hours later or whenever their lens clouding typically occurs they will return for further assessment and dispensing of solution if acceptable. subjects will use the solution for 5-9 days and return for a follow-up appointment. At each visit, subjects will complete an OSDI questionnaire and a Current Symptoms questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in corneal staining or corneal disruption as assessed with clinical biomicroscope | ocular safety examination | immediately after first use of solution and again in 5 to 9 days | 
| Comfort and vision quality as assessed by Ocular Surface Disease Index (OSDI) questionnaire | Subjects will answer the OSDI questionnairre (score of 0-48) used to assess symptoms related to comfort and vision. The survey will be done with the subjects regular solution and repeated after using the test solution | 5 to 9 days | 
| Comfort as assessed by Current Symptoms Survey (CSS) | Subjects will respond to the CSS survey (scores of 0-100 for various symptoms) - used to assess symptoms related to comfort and vision. The survey will be done with the subjects regular solution and repeated after using the test solution | 5 to 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens solution