Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: DT1 Toric contact lenses; Device: AO1DfA contact lenses

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigative Site CT-11
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • Alcon Investigative Site CT-27

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:

• Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
• Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
• Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
• Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
• History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
• Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.

Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Test, then Control; DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.	Device: DT1 Toric contact lenses; Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia); Other Names: Test; DAILIES TOTAL1 for Astigmatism (DT1 Toric); Device: AO1DfA contact lenses; Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia); Other Names: Control; Acuvue Oasys 1-Day for Astigmatism (AO1DfA)
Other: Control, then Test; AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.	Device: DT1 Toric contact lenses; Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia); Other Names: Test; DAILIES TOTAL1 for Astigmatism (DT1 Toric); Device: AO1DfA contact lenses; Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia); Other Names: Control; Acuvue Oasys 1-Day for Astigmatism (AO1DfA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion	A slit lamp will be used to observe axis orientation.	Day 1, 10 minutes after lens insertion, each product

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: astigmatism; silicone hydrogel contact lens; daily disposable; toric contact lens; axis orientation
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLO870-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