CompletedNot Applicable

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

United States36 participantsStarted 2018-04-09

Plain-language summary

Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir

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:• * 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.

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

Patient Subjective Symptoms and Wear Time Survey

Timeframe: 1 Month

Trial details

NCT IDNCT03525704

SponsorContamac Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-15

View on ClinicalTrials.gov More Contact Lens Complication trials

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.