Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

Overview

The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 6, 2020

Detailed Description

This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.

Interventions

  • Device: verofilcon A toric contact lenses
    • Daily disposable toric soft contact lenses

Arms, Groups and Cohorts

  • Experimental: DDT2 Toric
    • Verofilcon A toric contact lenses worn in both eyes

Clinical Trial Outcome Measures

Primary Measures

  • Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
    • Time Frame: Day 1, 10 minutes after lens insertion
    • Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.

Participating in This Clinical Trial

Inclusion Criteria

  • Able to understand and sign an informed consent form; – Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol; – Willing to NOT use rewetting/lubricating drops at any time during the study; – Other protocol-specified inclusion criteria may apply. Exclusion Criteria:

  • Any eye condition that would contraindicate contact lens wear, as determined by the Investigator; – History of eye surgery within the previous 12 months, as specified in the protocol; – Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear; – Other protocol-specified exclusion criteria may apply.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trial Lead, Vision Care, Study Director, Alcon Research, LLC

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