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Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Primary Purpose

Refractive Ametropia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LID015385 soft contact lenses
Comfilcon A soft contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Ametropia

Eligibility Criteria

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

Inclusion Criteria: Able to understand and sign an Informed Consent Form. Willing to attend all scheduled study visits as required per protocol. Willing and able to wear assigned study lenses as required per protocol. Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week. Manifest cylinder ≤ 0.75 diopter (D) in each eye. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any eye 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 eye surgery, including refractive surgery. Currently pregnant or breast-feeding. Monovision contact lens wearers. Daily disposable contact lens wearers. Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Family EyeCare Center
  • Winston Eye Care
  • Kurata Eye Care Center
  • East West Eye Institute
  • Dr.Elsa Pao, O.D
  • Gordon Schanzlin New Vision Institute
  • Complete Family Vision Care
  • Westview Optometry
  • OMEGA Vision Center PA, DBA Sabal Eye Care
  • Kindred Optics at Maitland Vision Center
  • Mid Florida Eye Center, PA
  • Eola Eyes
  • Vision Health Institute
  • Visual Performance Center Research & Development
  • Golden Vision
  • Advanced Eyecare Specialists
  • VisionPoint Eye Center
  • Franklin Park Eye Center, PC
  • Kannarr Eye Care, LLC
  • Optimum Vision Care
  • Fraser Eye Care Center
  • Dr. Schwartz Optometrist and Associates
  • Complete Eye Care of Medina
  • Fischer Laser Eye Center, LLC
  • Tekwnai Vision Center, Inc
  • Alterman, Modi & Wolter
  • Rochester Ophthalmological Group, PC
  • Asheville Eye Associates, PLLC
  • ProCare Vision Centers, Inc.
  • Midwest Vision Care
  • EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC
  • Wyomissing Optometric Center
  • West Bay Eye Associates
  • North Spartanburg Eye Center
  • Primary Eyecare Group, PC
  • Optometry Group, PLLC
  • Total Eye Care, PA
  • Advancing Vision Research, LLC
  • Beaumont Family Eye Care
  • Vision One Eyecare
  • Dawn M Rakich, OD
  • Clarke EyeCare Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LID015385

Biofinity

Arm Description

LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.

Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.

Outcomes

Primary Outcome Measures

Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)
Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).

Secondary Outcome Measures

Full Information

First Posted
September 9, 2019
Last Updated
May 19, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04085328
Brief Title
Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
Official Title
Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
March 26, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Detailed Description
Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
675 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LID015385
Arm Type
Experimental
Arm Description
LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.
Arm Title
Biofinity
Arm Type
Active Comparator
Arm Description
Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.
Intervention Type
Device
Intervention Name(s)
LID015385 soft contact lenses
Intervention Description
Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Intervention Type
Device
Intervention Name(s)
Comfilcon A soft contact lenses
Other Intervention Name(s)
BIOFINITY®
Intervention Description
Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Description
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Time Frame
Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
Title
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Description
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Time Frame
Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
Title
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)
Description
Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).
Time Frame
Up to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to understand and sign an Informed Consent Form. Willing to attend all scheduled study visits as required per protocol. Willing and able to wear assigned study lenses as required per protocol. Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week. Manifest cylinder ≤ 0.75 diopter (D) in each eye. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any eye 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 eye surgery, including refractive surgery. Currently pregnant or breast-feeding. Monovision contact lens wearers. Daily disposable contact lens wearers. Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Study Director
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Family EyeCare Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Winston Eye Care
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Kurata Eye Care Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
East West Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Dr.Elsa Pao, O.D
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Gordon Schanzlin New Vision Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Complete Family Vision Care
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Westview Optometry
City
San Diego
State/Province
California
ZIP/Postal Code
92129
Country
United States
Facility Name
OMEGA Vision Center PA, DBA Sabal Eye Care
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Kindred Optics at Maitland Vision Center
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Mid Florida Eye Center, PA
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Eola Eyes
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Vision Health Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Visual Performance Center Research & Development
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Golden Vision
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Advanced Eyecare Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33405
Country
United States
Facility Name
VisionPoint Eye Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Franklin Park Eye Center, PC
City
Franklin Park
State/Province
Illinois
ZIP/Postal Code
60131
Country
United States
Facility Name
Kannarr Eye Care, LLC
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Optimum Vision Care
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Fraser Eye Care Center
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Dr. Schwartz Optometrist and Associates
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
Complete Eye Care of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Fischer Laser Eye Center, LLC
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Tekwnai Vision Center, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Alterman, Modi & Wolter
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Asheville Eye Associates, PLLC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
ProCare Vision Centers, Inc.
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Midwest Vision Care
City
Piqua
State/Province
Ohio
ZIP/Postal Code
45356
Country
United States
Facility Name
EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Wyomissing Optometric Center
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
West Bay Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
North Spartanburg Eye Center
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Primary Eyecare Group, PC
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Optometry Group, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Advancing Vision Research, LLC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Beaumont Family Eye Care
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Facility Name
Vision One Eyecare
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Dawn M Rakich, OD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Clarke EyeCare Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

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