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 range18 Years
SexALL
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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
✓. 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:
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.
. 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.