Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses (NCT01839318) | Clinical Trial Compass
CompletedNot Applicable
Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses
30 participantsStarted 2013-04
Plain-language summary
The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.
Who can participate
Age range
18 Years – 44 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:
* Sign Informed Consent.
* Adapted soft contact lens wearer.
* Willing to wear contact lenses up to 12 hours and attend all study visits.
* Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
* Contact lens prescription within the power range specified in the protocol.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Any use of systemic or ocular medications that would contraindicate contact lens wear.
* Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
* Monocular (only 1 eye with functional vision) or fit with only 1 lens.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Known pregnancy.
* Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
* Participation in any clinical study within 30 days of Visit 1.
* Other protocol-defined exclusion criteria may apply.
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
Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours