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Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Primary Purpose

Refractive Errors

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Verofilcon A contact lenses

Etafilcon A contact lenses

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring Contact lens, Vision correction, Visual acuity, Daily disposable contact lens

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

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
Other protocol-specified exclusion criteria may apply.

Sites / Locations

Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sequence 1

Sequence 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03969290

First Posted

May 29, 2019

Last Updated

August 20, 2019

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT03969290

Brief Title

Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Official Title

Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

June 5, 2019 (Actual)

Primary Completion Date

August 5, 2019 (Actual)

Study Completion Date

August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractive Errors

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Contralateral

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Sequence 2

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Verofilcon A contact lenses

Other Intervention Name(s)

Precision1™

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Etafilcon A contact lenses

Other Intervention Name(s)

Acuvue® Moist

Intervention Description

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

Primary Outcome Measure Information:

Title

End of day (EOD) visual acuity at distance

Description

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

Time Frame

Day 1, after 8 hours of wear

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Other protocol-specified inclusion criteria may apply. Exclusion Criteria: 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 Other protocol-specified exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alcon Research

Organizational Affiliation

Alcon Research

Official's Role

Study Director

Facility Information:

Facility Name

Alcon Investigative Site

City

Jena

ZIP/Postal Code

07745

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

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