A 12-month prospective clinical trial of comfilcon A silicone-hydrogel contact lenses worn on a 30-day continuous wear basis☆

Abstract 

Purpose

To evaluate the clinical performance of comfilcon A (Biofinity) during 12 months of continuous wear compared to other silicone-hydrogel lenses.

Method

Forty-five subjects were fitted in one eye with the comfilcon A (test) lens. For 22 subjects, the other eye was fitted with lotrafilcon A (group A) and for the remaining 23 subjects the other eye was fitted with balafilcon A (group B). Twelve-month data are presented on 48 measured variables.

Results

There were no serious adverse events during the course of the study. A total of 33 subjects completed the study, with only 4 discontinuations for lens-related reasons, spread proportionately between the lenses. On preference scales, the test lens was superior to both control lenses for comfort (p<0.05) and overall preference (p<0.05) and in group A for vision (p<0.05). On grading scales, the test lens scored better than both control lenses for overall comfort (p<0.1 for group A, p<0.05 for group B), comfort during the day (p<0.05), end-of-day comfort (p<0.05) and overall preference (p<0.05), and better in group A for general vision quality (p<0.01), night vision quality (p<0.01) and handling (p<0.05). All lenses performed to a comparable degree on the basis of microcysts and corneal staining. There were significant differences between lenses in producing limbal redness (p<0.05), bulbar conjunctival hyperemia (p<0.1) and conjunctival NaFl staining (p<0.01) with the control lens in group A showing the greatest effect and the control lens in group B the least.

Conclusion

Comfilcon A offers performance advantages over first generation silicone-hydrogel materials for continuous wear.

Keywords: Contact lens, Silicone-hydrogel, Signs, Symptoms, Clinical trial