John R Buch1, Leilani Sonoda2, Jessica L Cannon2. 1. Johnson & Johnson Vision, Jacksonville, FL, United States. Electronic address: JBUCH@its.jnj.com. 2. Johnson & Johnson Vision, Jacksonville, FL, United States.
Abstract
PURPOSE: To determine the proportion of contact lens neophytes that can be successfully fitted with a photochromic contact lens, and to survey subjective performance outcomes compared to habitual spectacles. It was hypothesized that at least 50 % of lens fits would be successful. METHODS: Eleven sites enrolled contact lens neophytes with up-to-date spectacles. Subjects were fitted bilaterally with a photochromic Test contact lens (ACUVUE® OASYS with Transitions™) for one month of daily, reusable wear. Follow-up visits occurred at 1 week, 2 weeks (lenses replaced), and at 4 weeks after initial dispensing. The investigator judged lens fitting success based on overall assessment of physiology, mechanical fitting, comfort, vision, and handling at the 4-week visit. Following this visit, subjects returned to wearing habitual spectacles for one week and evaluated the performance of the study lens compared to their spectacles. RESULTS: From a total of 127 subjects who were dispensed contact lenses, 105 completed the study per protocol (mean age: 25.5 ± 5.9 years; 57 % female; 80.0 % Caucasian; 71 % with dark iris color). Investigators judged that 97 % of the contact lenses were fitted successfully after 4 weeks of wear; thus, the primary hypothesis was met. Among per-protocol subjects, 60 % reported better vision outdoors, 53 % better vision in changing lighting conditions, 62 % less squinting, and 66 % being less often bothered by bright light. Additionally, 95 % would recommend the lens to others, and 71 % would recommend their eye care practitioner if offered the lens. CONCLUSION: Greater than 95 % of subjects were successfully fitted with the photochromic contact lens based on professional judgement of physiology, mechanical fitting, comfort, vision, and handling. Subjects new to contact lens wear expressed positive opinions for the study contact lenses compared to their up-to-date spectacles.
PURPOSE: To determine the proportion of contact lens neophytes that can be successfully fitted with a photochromic contact lens, and to survey subjective performance outcomes compared to habitual spectacles. It was hypothesized that at least 50 % of lens fits would be successful. METHODS: Eleven sites enrolled contact lens neophytes with up-to-date spectacles. Subjects were fitted bilaterally with a photochromic Test contact lens (ACUVUE® OASYS with Transitions™) for one month of daily, reusable wear. Follow-up visits occurred at 1 week, 2 weeks (lenses replaced), and at 4 weeks after initial dispensing. The investigator judged lens fitting success based on overall assessment of physiology, mechanical fitting, comfort, vision, and handling at the 4-week visit. Following this visit, subjects returned to wearing habitual spectacles for one week and evaluated the performance of the study lens compared to their spectacles. RESULTS: From a total of 127 subjects who were dispensed contact lenses, 105 completed the study per protocol (mean age: 25.5 ± 5.9 years; 57 % female; 80.0 % Caucasian; 71 % with dark iris color). Investigators judged that 97 % of the contact lenses were fitted successfully after 4 weeks of wear; thus, the primary hypothesis was met. Among per-protocol subjects, 60 % reported better vision outdoors, 53 % better vision in changing lighting conditions, 62 % less squinting, and 66 % being less often bothered by bright light. Additionally, 95 % would recommend the lens to others, and 71 % would recommend their eye care practitioner if offered the lens. CONCLUSION: Greater than 95 % of subjects were successfully fitted with the photochromic contact lens based on professional judgement of physiology, mechanical fitting, comfort, vision, and handling. Subjects new to contact lens wear expressed positive opinions for the study contact lenses compared to their up-to-date spectacles.