Clinical performance of senofilcon A with and without a photochromic additive
John R Buch O.D. M.S. F.A.A.O.
David Ruston BSc FCOptom DipCL FAAO FIACLE
John Meyler BSc FCOptom DipCL
Jessica Lin Cannon MSc.
Purpose: The purpose of this study was to validate the clinical performance of senofilcon A with a photochromic additive (Test) against a similar lens without the additive (Control).
Method: Two similar studies were combined in the analysis. Both studies were prospective, bilateral, partial-subject masked, daily-wear reusable, dispensing, and had the same eligibility criteria and the same study lens parameters. The dispensing periods were 2 weeks each in a randomized ABB or BAA design, resulting in a 6-week study per subject. Follow-up visits occurred at 2, 4, and 6 weeks after dispensing with safety measures collected at each visit. Preferences were asked at the 4-week follow-up, and overall subjective responses were collected at the 6-week follow-up.
Results: A total of 229 cohort subjects age 32.4 +/- 7.89 were included in the analysis. There were no physiological differences found between the Test and Control lenses at any visit, and the physical fit of all study lenses were judged acceptable. Preferences for the Test lens were statistically superior for all outdoor and indoor items, including overall preference outdoors (5.61 +/- 1.23), overall preference indoors (4.20 +/- 0.98), and overall preference while using computer screens and digital devices (3.39 +/- 0.71). Overall vision (6.3 +/- 1.1) and comfort (3.3 +/- 1.4) of the Test lens was statistically superior to the Control lens after six weeks of wear.
Conclusions: The senofilcon A lens with a photochromic additive performed just as well as the same lens without the additive in all safety measures, and exceeded the Control lens in all efficacy measures that included lens preferences and other important subjective measures for both the activated and inactivated states of the Test lens. The patient can expect benefits from the Test lens both outdoors and indoors.
1st Author Biography: Dr. John Buch is a Senior Principal Research Optometrist for Johnson & Johnson Vision Care and a Fellow of the American Academy of Optometry. John received his O.D. degree from The Ohio State University and his M.S. degree from the Indiana University. His thesis investigated the effect that contact lens designs have on ocular surface physiology. Since joining J&J in 1998, John has been the clinical project lead on several marketed products, most recently ACUVUE OASYS with Transitions. He has a research interest in the psychophysical and neurobiological basis of visual perception and the clinical evaluation of contact lens performance.
*Data correct at the time of submission to BCLA by NCC.