Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

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 Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: verofilcon A toric contact lenses

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DDT2 Toric; Verofilcon A toric contact lenses worn in both eyes	Device: verofilcon A toric contact lenses; Daily disposable toric soft contact lenses; Other Names: DDT2 Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of lenses with axis orientation within ±30° from the intended axis, 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.	Day 1, 10 minutes after lens insertion

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): August 6, 2020
• Study Completion (Actual): August 6, 2020

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Astigmatism; Daily disposable; Toric contact lens; Silicone hydrogel contact lens; Axis orientation
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CLA306-C003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No