Lehfilcon A contact lenses
DeviceInvestigational soft contact lenses for daily wear worn in Part A of the study
Other names: LID018869
NCT Number: NCT04532099
The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Alcon Investigator 6356, Longwood, Florida, United States
Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.
Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Investigational soft contact lenses for daily wear worn in Part A of the study
Other names: LID018869
Commercially available soft contact lenses for daily wear worn in Part A of the study
Other names: AOHP, ACUVUE OASYS® with HYDRACLEAR® PLUS
Commercially available soft contact lenses for daily wear worn in Part B of the study
Other names: CooperVision® Biofinity®
For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study
Other names: CLEAR CARE®
Time frame: Day 30, each study lens type
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Alcon Research
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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