PURPOSE: To evaluate the clinical effectiveness and safety of a new dual-disinfectant investigational multi-purpose solution (MPS) for contact lens care compared to a commercially available MPS when used by habitual planned replacement soft contact lens (CL) wearers to clean and disinfect their CLs.

METHODS: Habitual planned replacement spherical soft CL wearers ≥18 years of age were recruited across 18 sites for a 3-month study in which they were randomized 1:1 to use either the study (test) MPS or a comparator (control) MPS (ReNu Advanced) as their CL care system. Key effectiveness outcomes included overall comfort and vision, averaged over all scheduled follow-up visits, and the proportion of eyes with maximum degree of front-surface deposits grade ≤2 over all scheduled follow-up visits. The key safety outcome measure was the proportion of eyes with slit-lamp findings >grade 2 at any follow-up visit. Each key outcome was evaluated statistically using a one-sided non-inferiority test with a one-sided alpha risk of 0.025.

RESULTS: In total, 143 (286 eyes) were dispensed the test MPS and 151 (302 eyes) were dispensed the control MPS. For each effectiveness outcome, the test MPS was non-inferior to the control MPS: mean (SD) comfort ratings were 91.7 (10.0) and 90.7 (10.8), respectively, and vision ratings were 95.5 (6.7) and 94.3 (7.8), respectively. Front surface deposits were grade ≤2 for 99.3% with the test MPS and 97.7% with the control MPS. No subject with the test MPS had incidence of slit-lamp findings >grade 2, with demonstrated non-inferiority to the control MPS. There were also no significant, severe, or unanticipated MPS-related adverse events in either arm; all adverse events were mild and resolved by the conclusion of the study.

CONCLUSIONS: The present study demonstrates that this investigational MPS formulation is safe and effective when used as directed and supports robust comfort and vision for planned replacement soft CL wearers.