Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

Completed · Not applicable

Conditions studied: Refractive Errors

In brief

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

Key facts

Study ID

NCT04631796

Run by

Alcon Research

People needed

36

Starts

2020-12-03

Expected to finish

2020-12-31

Last updated by the study team

2022-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
• Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• Other protocol-defined inclusion criteria may apply.

You may not qualify if…

• Any condition that contraindicates contact lens wear, as determined by the Investigator.
• Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
• History of refractive surgery or plan to have refractive surgery during the study.
• Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
• Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
• Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
• Monovision or multifocal contact lens wear.
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Alcon Investigative Site — Orlando, Florida, United States
• Alcon Investigative Site — Bloomington, Illinois, United States
• Alcon Investigative Site — Powell, Ohio, United States

Full record on ClinicalTrials.gov

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