Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort (NCT00349843) | Clinical Trial Compass
CompletedPhase 4
Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort
Canada30 participantsStarted 2005-06
Plain-language summary
The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.
Who can participate
Age range
16 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
. Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
. Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
. Is correctable to a visual acuity of 6/6 or better with their habitual correction.
. Is willing and able to follow product usage instructions and maintain the visit schedule.
. Is at least 18 years of age and has full legal capacity to volunteer.
. Can be successfully fitted with study lens type.
. Has read, understood and signed an Information Consent Letter.
. Has a distance contact lens prescription is between -0.50 D and -9.00 D
Exclusion criteria
. Has any active ocular disease.
. Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
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
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The primary objective of this study is to compare corneal staining over time in
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a group of individuals who wear soft contact lenses on a daily wear basis,
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whilst they sequentially use two different contact lens care regimens.
. Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
. Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
. Is using topical ocular prescription or any topical over-the-counter medication.
. Is actively involved in any other research/clinical study.
. Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.