CompletedNot Applicable

Scleral Contact Lens Insertion Solution Study

United States30 participantsStarted 2017-11-27

Plain-language summary

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 range18 Years

SexALL

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.

What they're measuring

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

Comfort and vision quality as assessed by Ocular Surface Disease Index (OSDI) questionnaire

Timeframe: 5 to 9 days

Comfort as assessed by Current Symptoms Survey (CSS)

Timeframe: 5 to 9 days

Trial details

NCT IDNCT03612284

SponsorJennifer Fogt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-30

View on ClinicalTrials.gov More Irregular; Contour of Cornea trials