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

NCT04254003 | Completed FDA Device

• 1 other identifier: CLO870-C003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Refractive Errors

Keywords

toric contact lens; daily disposable; silicone hydrogel contact lens; axis orientation; astigmatism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test, then Control

OTHER

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; Device: AO1DfA contact lenses

Control, then Test

OTHER

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; Device: AO1DfA contact lenses

Interventions

DT1 Toric contact lenses DEVICE

Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)

Also known as: Test, DAILIES TOTAL1 for Astigmatism (DT1 Toric)

Control, then Test; Test, then Control

AO1DfA contact lenses DEVICE

Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)

Also known as: Control, Acuvue Oasys 1-Day for Astigmatism (AO1DfA)

Control, then Test; Test, then Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (2)

Alcon Investigative Site CT-11

Maitland, Florida, 32751, United States

Location

Alcon Investigative Site CT-27

Eden Prairie, Minnesota, 55344, United States

Location

MeSH Terms

Conditions

Refractive Errors; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: February 5, 2020
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)