Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

NCT04908488 | Completed Results FDA Device

• 1 other identifier: CLA306-P001
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Conditions

Refractive Errors; Ametropia; Astigmatism

Keywords

Contact Lenses; Disposable

Outcome Measures

Primary Outcomes (1)

• Least Squares Mean Distance VA (logMAR) With Study Lenses

  Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

  Day 8 (-0/+3 days), each study lens type

Study Arms (2)

P1fA, then AMfA

OTHER

Verofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Device: Verofilcon A toric contact lenses; Device: Etafilcon A toric contact lenses

AMfA, then P1fA

OTHER

Etafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Device: Verofilcon A toric contact lenses; Device: Etafilcon A toric contact lenses

Interventions

Verofilcon A toric contact lenses DEVICE

Soft contact lenses for optical correction of astigmatism

Also known as: PRECISION1™ for Astigmatism, P1fA

AMfA, then P1fA; P1fA, then AMfA

Etafilcon A toric contact lenses DEVICE

Soft contact lenses for optical correction of astigmatism

Also known as: 1-DAY ACUVUE MOIST® for ASTIGMATISM, AMfA

AMfA, then P1fA; P1fA, then AMfA

Eligibility Criteria

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

You may qualify if:

• Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.

You may not qualify if:

• Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
• Any spherical monovision and multifocal lens wearers.
• Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (8)

Alcon Investigator 8135

Los Angeles, California, 90012, United States

Location

Alcon Investigator 8062

Oakland, California, 94607, United States

Location

Alcon Investigator 6355

Orlando, Florida, 32803, United States

Location

Alcon Investigator 6614

Franklin Park, Illinois, 60131, United States

Location

Alcon Investigator 6645

Shawnee Mission, Kansas, 66204, United States

Location

Alcon Investigator 3382

Wyomissing, Pennsylvania, 19610, United States

Location

Alcon Investigator 6353

Memphis, Tennessee, 38111, United States

Location

Alcon Investigator 2786

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Refractive Errors; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr. Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will receive treatment based upon the randomized treatment sequence assignment.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 1, 2021
• Study Start: July 1, 2021
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: October 18, 2022
• Results First Posted: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)