Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

NCT03969290 | Completed

• 1 other identifier: CLE383-P001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Conditions

Refractive Errors

Keywords

Contact lens; Vision correction; Visual acuity; Daily disposable contact lens

Outcome Measures

Primary Outcomes (1)

• End of day (EOD) visual acuity at distance

  Visual acuity (VA) will be measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity.

  Day 1, after 8 hours of wear

Study Arms (2)

Sequence 1

EXPERIMENTAL

Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.

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

Sequence 2

ACTIVE COMPARATOR

Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.

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

Interventions

Verofilcon A contact lenses DEVICE

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Also known as: Precision1™

Sequence 1; Sequence 2

Etafilcon A contact lenses DEVICE

Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Also known as: Acuvue® Moist

Sequence 1; Sequence 2

Eligibility Criteria

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

You may qualify if:

• Able to understand and sign an approved Informed Consent form
• Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
• Best corrected VA of logMAR 0.10 or better in each eye
• Willing to discontinue artificial tears and rewetting drops during the study
• Able to wear contact lenses within the protocol-specified sphere power range

You may not qualify if:

• Any anterior segment infection, inflammation, or abnormality or disease 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 ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment
• Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Investigative Site

Jena, 07745, Germany

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Alcon Research

  Alcon Research

  STUDY DIRECTOR

Study Design

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

Model Details: Contralateral

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: June 5, 2019
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)