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Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Primary Purpose

Refractive Error

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FID122819 contact lenses

Stenfilcon A contact lenses

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring contact lens, silicone hydrogel, daily disposable, visual acuity

Eligibility Criteria

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

Inclusion Criteria:

Able to understand and sign an IRB-approved Informed Consent Form;
Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Any anterior segment infection, inflammation, 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;
Ocular or intraocular surgery within the previous 12 months or planned during the study;
Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
Any previous or current wear of MYDAY;
Habitually wearing monovision or multifocal lenses during the last 3 months;
Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
Other protocol-defined exclusion criteria may apply.

Sites / Locations

Alcon Investigative Site
Alcon Investigative Site
Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

FID122819, then stenfilcon A

Stenfilcon A, then FID122819

Arm Description

FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week

Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week

Outcomes

Primary Outcome Measures

Visual Acuity (VA)

VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.

Secondary Outcome Measures

Full Information

NCT ID

NCT03095027

First Posted

March 23, 2017

Last Updated

January 8, 2019

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT03095027

Brief Title

Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Official Title

Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

April 19, 2017 (Actual)

Primary Completion Date

May 15, 2017 (Actual)

Study Completion Date

May 15, 2017 (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

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

6. Conditions and Keywords

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

Refractive Error

Keywords

contact lens, silicone hydrogel, daily disposable, visual acuity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Masking Description

Alcon Observer and Sponsor personnel were also masked.

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FID122819, then stenfilcon A

Arm Type

Other

Arm Description

Arm Title

Stenfilcon A, then FID122819

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

FID122819 contact lenses

Other Intervention Name(s)

DDT2, Verofilcon A

Intervention Description

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

Intervention Type

Device

Intervention Name(s)

Stenfilcon A contact lenses

Other Intervention Name(s)

MyDay®

Intervention Description

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Primary Outcome Measure Information:

Title

Visual Acuity (VA)

Description

Time Frame

Baseline/Dispense (Day 1), Week 1, each product

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to understand and sign an IRB-approved Informed Consent Form; Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months: Manifest cylinder of ≤ 0.75 diopter (D) in each eye; Best corrected visual acuity (BCVA) of 20/25 or better in each eye; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any anterior segment infection, inflammation, 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; Ocular or intraocular surgery within the previous 12 months or planned during the study; Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear; Any previous or current wear of MYDAY; Habitually wearing monovision or multifocal lenses during the last 3 months; Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment; Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; Other protocol-defined exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sr. Clinical Manager, Trial Management Operations

Organizational Affiliation

Alcon, A Novartis Division

Official's Role

Study Director

Facility Information:

Facility Name

Alcon Investigative Site

City

Longwood

State/Province

Florida

ZIP/Postal Code

32779

Country

United States

Facility Name

Alcon Investigative Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Alcon Investigative Site

City

Johns Creek

State/Province

Georgia

ZIP/Postal Code

30097

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

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