A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solu… (NCT05565937) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution
United States295 participantsStarted 2023-04-12
Plain-language summary
Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.
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
. Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed
. Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations
. Is a habitual wearer (at least 3 months)
. Has typically cleaned and disinfected their pre-study contact lenses daily
. Must have spectacle correctable distance visual acuity through spherocylindrical refraction to 40 letters (0.14 logarithm of the minimal angle of resolution (logMAR) or better in each eye, at 2 meters distance with high contrast chart
. Has clear central corneas and is free of any anterior segment disorders
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
Overall Comfort Averaged Over All Follow-up Visits
Timeframe: Assessed at all follow-up visits through 3 months.
2
Vision Averaged Over All Follow-up Visits
Timeframe: Assessed at all follow-up visits through 3 months.
3
The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits.
Timeframe: Assessed at all follow-up visits through 3 months.
4
The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.
. Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses
. Requires lens correction in both eyes
Exclusion criteria
. Is currently using a hydrogen-peroxide cleaning and disinfecting solution
. Participated in any drug or device clinical investigation within 30 days prior to entry into this study
. Is a female of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following conditions:
. Has worn gas permeable (GP) lenses within the last 30 days
. Has worn polymethylmethacrylate (PMMA) lenses within the last three months
. Has typically worn their pre-study contact lenses on an extended wear basis, sleeping in their lenses one night or more per week, during the last year
. Has any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study
. Subjects with an active ocular disease, or who are using any ocular medication.