Abstract
Purpose:
To evaluate the amount of upper lid margin staining (ULMS) when using three different soft contact lenses (SCL) in combination with four different contact lens care solutions.
Methods:
Habitual SCL wearers (n=237) were enrolled at three different sites and randomized to wear one of three 2-week disposable SCL types (etafilcon A, galyfilcon A, or senofilcon A) on a daily wear basis for 10-14 days. Each participant was assigned to use four different lens care solutions (A: polyaminopropyl biguanide + polyquaternium; B: POLYQUAD + Aldox; C: alexidine + polyquaternium-1; D: hydrogen peroxide) in a randomly-assigned order, and received a new pair of lenses with each new solution. There was a washout period of at least four days (daily disposable lenses) between solutions. ULMS was assessed with lissamine green and sodium fluorescein dyes. Horizontal length and sagittal width of ULMS were graded from 0 to 3, following the grading scheme proposed by Korb et al. For each dye, horizontal and sagittal grades were averaged in order to derive a final ULMS grade. Statistical analysis was controlled for baseline ULMS and was performed to compare the three multipurpose (test) solutions to the hydrogen peroxide (control) solution with respect to final ULMS grade at the two-week follow-up visit.
Results:
Complete data for all four solutions were available from 206 participants (87%). The final ULMS grades, expressed as Least Square Means (±StErr), when wearing etafilcon A were 0.93 (±0.17), 0.89 (±0.17), 1.03 (±0.17), and 0.90 (±0.17) for solutions A, B, C, and D, respectively. The final ULMS grades when wearing galyfilcon A were 0.88 (±0.17), 1.07 (±0.18), 1.20 (±0.18), and 1.11 (±0.18) for solutions A, B, C, and D, respectively. For senofilcon A, the final ULMS grades were 1.04 (±0.17), 1.00 (±0.18), 0.95 (±0.17), and 1.01 (±0.17) for solutions A, B, C, and D, respectively. No differences in final ULMS grades were shown between the test solutions and the control solution across lens materials, except for solution A vs. solution D for participants wearing galyfilcon A (p=0.0092).
Conclusions:
The final ULMS grades for all solutions tested were very similar, and showed levels typically found in SCL wearers. Although statistically significant, the difference in final ULMS grade between solution A and D while wearing galyfilcon A does not appear to be clinically meaningful.
Keywords: 477 contact lens •
466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials