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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in corneal staining or corneal disruption as assessed with clinical biomicroscope
Timeframe: immediately after first use of solution and again in 5 to 9 days
2
Comfort and vision quality as assessed by Ocular Surface Disease Index (OSDI) questionnaire
Timeframe: 5 to 9 days
3
Comfort as assessed by Current Symptoms Survey (CSS)