Study Rationale and Purpose. The purpose of this study is to evaluate biocompatibility of an investigational contact lens compared to marketed contact lenses (PureVision/Biofinity) which have been pre- cycled in OPTI-FREE RepleniSH multi-purpose disinfecting solution (RepleniSH) and/or Biotrue multi-purpose solution (Biotrue). The primary endpoint (average % area of corneal staining) was selected to fulfill the primary objective of the study. RepleniSH was chosen as a representative solution containing the Polyquarterium-1 preservative and Biotrue was chosen as a representative solution containing the polyaminopropyl biguanide (PHMB) preservative.
Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population. The primary endpoint was selected to fulfil the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Oasys 1-Day, MyDay, and Moist contact lenses were chosen as the control products because these lenses have the same wear modality. The new contact lens in development is intended for the optical correction of refractive myopia in persons with non-diseased eyes. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Study Rationale and Purpose. The contact lenses for this study are intended for the optical correction of refractive myopia in persons with non-diseased eyes who are dryness symptomatic with their habitual weekly/monthly contact lenses. The primary purpose of this study is to conduct a pilot study with DAILIES TOTAL1 and Acuvue Oasys 1-Day to guide the protocol development of the subsequent larger scale head- to-head phase 4 trial. Additionally, this study is being conducted to re-fit habitual weekly/monthly symptomatic wearers into DAILIES TOTAL1 and Acuvue Oasys 1-Day The primary endpoint was selected to support the overall study objective. Procedures for measurement of this endpoint are standard in eye care professional practice. The design of this study is justified based upon preclinical and clinical testing, as described within the product´s Instructions for Use. Acuvue Oasys 1-Day contact lenses were chosen as the control product because these lenses have the same wear modality and a similar material to the DAILIES TOTAL1 lenses. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Study Rationale and Purpose. PRECISION1 is a new daily disposable silicone hydrogel contact lens with a material that combines high oxygen transmissibility with a low modulus of elasticity. PRECISION1 contact lenses are intended for the optical correction of refractive ametropia in persons with non-diseased eyes requiring subjects to wear spectacles for vision correction. The purpose of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to INFUSE contact lenses
Study Rationale and Purpose. The new contact lens in development is intended for the optical correction of refractive ametropia in persons with non-diseased eyes. The purpose of this study is to obtain on-eye performance data to inform contact lens product development. The primary endpoint was selected to address the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Biofinity contact lenses were chosen as the control product because these lenses have the same wear modality and replacement schedule.
Study Rationale and Purpose. The new contact lens in development is intended for the optical correction of refractive ametropia in persons with non-diseased eyes. The purpose of this study is to evaluate performance of two commercially available daily wear frequent replacement silicone hydrogel soft contact lenses as compared to investigational test product (LID018869) to obtain on-eye performance data The primary endpoint was selected to address the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments.
Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population. The primary endpoint was selected to fulfill the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Clariti 1 Day contact lenses were chosen as the control product because these lenses have the same wear modality. The new contact lens in development is intended for the optical correction of refractive myopia in persons with non-diseased eyes. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to aid contact lens product development. The primary and secondary endpoints were selected to fulfil the primary and secondary objectives of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon FDA approval and information, as described within the Package Inserts. BIOFINITY contact lenses were chosen as the control product because these lenses have the same wear modality, material, and parameters to the test product BIOFINITY ENERGYS, and are the spherical design as compared to the aspherical design, respectively. There are no immediate plans to submit the results of this early clinical development study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
