Rationale for Study Design. In this clinical trial, the safety and performance of the investigational contact lens will be compared to the commercially available Biofinity contact lens in a double-masked, parallel-group design with approximately 12 months of exposure. The study is designed primarily following the recommendations for a new extended wear contact lens material from ISO 11980:2012 and the US FDA 510(k) guidance document for reporting format.
Rationale for Study Design. In this clinical trial, the performance of the investigational DD T2 lens will be compared to the commercially available DT1 (delefilcon A) lens in a double-masked, parallel-group design with approximately 3 months of exposure. The study is designed following the recommendations for registration from ISO 11980:2012 and the US FDA 510(k) guidance document.
Rationale for Study Design. The purpose of this clinical study is to evaluate effectiveness and safety of the TFNT20 when implanted to replace the natural lens following cataract removal in at least one eye based on a new Alcon Toric calculator that incorporates ocular trends in Toric IOL planning.
Rationale for Study Design. The purpose of this study is to clinically qualify the bench studies and model predictions of visual performance of the TFNT00 IOL by demonstrating the non-inferiority in binocular visual performance to 839MP IOL and to characterize the low contrast performance and patient satisfaction with both IOLs.
Rationale for Study Design. This study design is justified based upon an evaluation of the results of relevant preclinical and clinical testing, as described within the package inserts. The crossover design will ensure that the same subject is exposed to both the test and comparator lens materials; study will include only those subjects who are current wearers of spherical soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Furthermore, the subjects will not be permitted to use lubrication/rewetting drops during the duration of the study as this may confound the primary effectiveness endpoint. The study will exclude any habitual DT1and Infuse contact lens wearers in the past 3 months prior to consent in order to reduce potential bias of wearers to their habitual contact lenses. The study will also exclude subjects who wish to wear their contact lenses in monovision modality during the study and multifocal lens wearers.
Rationale for Study Design. This study design was selected to include symptomatic subjects as the appropriate population for this trial. Subjects will be fitted with their optimal habitual prescription and wear for approximately one week before wearing the test and control lenses. They will then be questioned again for symptoms of digital eye fatigue, with further assurance that any fatigue related symptoms are not related to a wrong prescription or old lenses that may have deposits or poor surface and thus inclusion in the study is appropriate. The age of the study population is necessary to avoid confounding with the natural lessening of accommodation with an early presbyopic population. The remaining aspects of the study design are well established.
Rationale for Study Design. In this study, the on-eye performance of the investigational DACP Digital lens and the commercially available DACP lens will be assessed in a prospective, double-masked, bilateral crossover design with 7 ± 2 days of exposure to each study lens. The study design as well as the exposure duration of study lenses is supported by the nonclinical and clinical data presented in the IB. The study design is well-established.
