Common use of Risks and Benefits Clause in Contracts

Risks and Benefits. Contact lenses may offer improved peripheral vision and the convenience of not wearing spectacles. Material properties and design characteristics of DD T2 are features consistent with successful contact lens wear. Based upon nonclinical testing and documented rationale for applicability of test results, DD T2 are assessed to be non-toxic and biocompatible for on-eye use. DT1 lenses are for daily wear use under a DD wear modality; further details on any known potential risks and benefits can be found in the package insert. DD T2 and DT1 are not intended for use with a cleaning/disinfecting solution, and the biocompatibility with lens care solutions and any associated clinical effects are unknown. A summary of the known potential risks and benefits associated with DD T2 can be found in the IB. Risks are minimized by compliance with the eligibility criteria and study procedures, and through close supervision by a licensed clinician during exposure to the study lenses. The potential xxxxx associated with on-eye exposure to the new lens materials include toxicity response, blurred vision, and ocular discomfort. In general, the risks with DD T2 are anticipated to be similar to other marketed DD soft contact lenses. There may also be unknown risks with the use of DD T2. Risks to subjects in this clinical study will be minimized by compliance with the eligibility criteria and study procedures, clinical oversight, and monitoring. Site personnel will educate subjects on proper hygiene and lens handling, and compliance with the use of contact lenses according to the protocol. Subjects should be instructed not to wear contact lenses while sleeping or swimming due to increased risk of infection. Site personnel should advise the subjects to remove contact lenses and return for prompt follow-up of symptoms such as ocular discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia.‌‌‌‌‌ Refer to the IB for additional information.

Risks and Benefits. The clinical investigation process risks are managed through appropriate training and monitoring according to the protocol-specific monitoring plan. Investigational device risks, including risks associated with use of device and methods and procedures for application of device, are defined in the package insert and are managed through review of safety assessments outlined in this protocol. Contact lenses may offer improved peripheral vision and the convenience of not wearing spectacles. Material properties and design characteristics of DD T2 the test contact lens are features consistent with successful contact lens wear. Based upon nonclinical testing PRECISION1 and documented rationale for applicability of test results, DD T2 are assessed to be non-toxic and biocompatible for on-eye use. DT1 Biotrue contact lenses are for daily wear use under a DD daily disposable wear modality; further details on any known potential risks and benefits can be found in the package insert. DD T2 PRECISION1 and DT1 Biotrue contact lenses are not intended for use with a cleaning/disinfecting solution, and the biocompatibility with lens care solutions and any associated clinical effects are unknown. A summary of the known potential risks and benefits associated with DD T2 PRECISION1 can be found in the IBpackage insert. Risks are minimized by compliance with the eligibility criteria and study procedures, and through close supervision by a licensed clinician during exposure to the study lenses. The potential xxxxx associated with on-eye exposure to the new lens materials include toxicity response, blurred vision, and ocular discomfort. In general, the risks with DD T2 are anticipated to be similar to other marketed DD soft contact lenses. There may also be unknown risks with the use of DD T2. Risks to subjects in this clinical study will be minimized by compliance with the eligibility criteria and study procedures, clinical oversight, and monitoring. Site site personnel will educate subjects on proper hygiene and lens handling, and compliance with the use of contact lenses according to the protocol. Subjects should be instructed not to wear contact lenses while sleeping or swimming due to increased risk of infectionswimming. Site The site personnel should will also advise the subjects to remove contact lenses and return for prompt follow-up of symptoms symptoms, such as ocular discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia.‌‌‌‌‌ hyperemia. There may also be unknown risks to use of these study contact lenses. Any risk to subjects in this clinical study will be minimized by compliance with the eligibility criteria and study procedures, clinical oversight, and monitoring. There may also be unknown risks to use of the comparator. Any risk to subjects in this clinical study will be minimized by compliance with the eligibility criteria and study procedures, clinical oversight and monitoring. Refer to the IB package insert for additional information.

Risks and Benefits. Contact lenses may offer improved peripheral vision and the convenience of not wearing spectacles. Material properties and design characteristics Biofinity contact lenses are approved for extended wear for up to 6 nights/7 days of DD T2 are features consistent with successful contact lens continuous wear. Based upon nonclinical testing and documented rationale for applicability of test results, DD T2 are assessed to be non-toxic and biocompatible for on-eye use. DT1 lenses are for daily wear use under a DD wear modality; further Further details on any known potential risks and benefits can be found in the package insert. DD T2 Material properties and DT1 design characteristics of the investigational (not approved by the FDA) contact lenses are not intended consistent with successful contact lens wear. To date, supportive results from preclinical tests and documented rationale for use with a cleaning/disinfecting solutionapplicability of test results, and the biocompatibility previous clinical studies, described in the IB, provide a basis for the anticipated acceptable performance and safety profile of the contact lenses for up to 6 continuous nights of extended wear with lens care solutions planned weekly replacement in the upcoming 12-month registration study. This study will evaluate any long term or new risks with the extended wear of contact lenses and any associated clinical effects are unknownhow these risks compare to a marketed extended wear control lens. A summary of the known and potential risks and benefits associated with DD T2 can be found contact lenses is presented in the IB. Risks are minimized by compliance with the eligibility criteria and study procedures, and through close supervision by a licensed clinician during exposure to the study lenses. The potential xxxxx associated with on-eye exposure to the new lens materials include toxicity response, blurred vision, and ocular discomfort. In generalUnder the conditions of a clinical study, the risks with DD T2 are anticipated to be similar to other marketed DD soft contact lenses. There may also be unknown risks with the use of DD T2. Risks to subjects in this clinical study will be minimized by which include compliance with the eligibility criteria and subject selection criteria, oversight by study proceduresInvestigators, clinical oversightadequate informed consent, subject instructions, scheduled lens wear/replacement, and monitoringfrequent follow-up visits, risks to study subjects are controlled and minimized. Site personnel will educate subjects on proper hygiene and lens handling, and compliance with the use of contact lenses according to the protocol. Subjects should be instructed not to wear contact lenses while sleeping or swimming due to increased risk of infection. Site personnel should advise the subjects to remove contact lenses and return for prompt follow-up of symptoms such as ocular discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia.‌‌‌‌‌ hyperemia. Refer to the IB for additional information.

Risks and Benefits. Contact lenses may offer improved peripheral vision and the convenience of not wearing spectacles. Material properties and design characteristics of DD T2 the contact lens in development are features consistent with successful contact lens wear. Based upon nonclinical non-clinical testing and and/or documented rationale for applicability of test resultsresults to the IP, DD T2 are the new contact lens in development is assessed to be non-toxic and biocompatible for on-eye use. DT1 The new contact lens in development and the 3 control contact lenses are for daily wear use under a DD wear modality; further details on any known potential risks and benefits can be found in the package insert. DD T2 and DT1 are not intended for use with a cleaning/disinfecting solution, and the biocompatibility with lens care solutions and any associated clinical effects are unknown. A summary of the known potential risks and benefits associated with DD T2 the new contact lens in development can be found in the IBInvestigator’s Brochure. There may also be unknown risks with the use of the new contact lens. Risks are minimized by compliance with the eligibility criteria and study procedures, and through close supervision by a licensed clinician during Alcon - Business Use Only Protocol - Clinical‌‌‌ Document: TDOC-0054506 Status: Effective Page 12 of 38 exposure to the study lenses. The potential xxxxx associated with on-eye exposure to the new lens materials include toxicity response, blurred vision, vision and ocular discomfort. In general, the risks with DD T2 the new contact lens in development are anticipated to be similar to other marketed DD daily disposable soft contact lenses. There may also be unknown risks with the use of DD T2. Risks to subjects in this clinical study will be minimized by compliance with the eligibility criteria and study procedures, clinical oversight, and monitoring. Site The site personnel will educate subjects on proper hygiene and lens handling, and compliance with the use of contact lenses according to the protocol. Subjects should be instructed not to wear contact lenses while sleeping or swimming due to increased risk of infectionswimming. Site The site personnel should will also advise the subjects to remove contact lenses and return for prompt follow-up of symptoms symptoms, such as ocular discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia.‌‌‌‌‌ Refer to the IB for additional informationhyperemia.