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Product Performance of a New Silicone Hydrogel Contact Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
kalifilcon A
delefilcon A
senofilcon A
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.
  • myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
  • correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye.
  • free of any anterior segment disorders.
  • adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.
  • access to internet connection and personal email to send/receive emails.
  • habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.

Exclusion Criteria:

  • participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
  • have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
  • have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.
  • refractive astigmatism of greater than 0.75 D in either eye.
  • anisometropia (spherical equivalent) of greater than 2.00 D.
  • amblyopic.
  • have had any corneal surgery (e.g., refractive surgery).

Sites / Locations

  • Bausch Site 433
  • Bausch Site 431
  • Bausch Site 406
  • Bausch Site 430
  • Bausch Site 419
  • Bausch Site 435
  • Bausch Site 432
  • Bausch Site 409
  • Bausch Site 416
  • Bausch Site 415
  • Bausch Site 434
  • Bausch Site 405
  • Bausch Site 412
  • Bausch Site 401
  • Bausch Site 437
  • Bausch Site 414
  • Bausch Site 413
  • Bausch Site 421
  • Bausch Site 429
  • Bausch Site 422
  • Bausch Site 407
  • Bausch Site 418
  • Bausch Site 424
  • Bausch Site 403
  • Bausch Site 417
  • Bausch Site 411
  • Bausch Site 423
  • Bausch Site 425
  • Bausch Site 428
  • Bausch Site 420
  • Bausch Site 427
  • Bausch 410
  • Bausch Site 408
  • Bausch Site 404
  • Bausch Site 426

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

kalifilcon A

delefilcon A

senofilcon A

Arm Description

kalifilcon A daily disposable contact lens

DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses

Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

Outcomes

Primary Outcome Measures

Mean Change in logMAR Contact Lens Visual Acuity
logMAR is the logarithm of the minim angle of resolution
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"

Secondary Outcome Measures

Full Information

First Posted
May 21, 2021
Last Updated
June 17, 2021
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT04901897
Brief Title
Product Performance of a New Silicone Hydrogel Contact Lens
Official Title
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
October 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
kalifilcon A
Arm Type
Experimental
Arm Description
kalifilcon A daily disposable contact lens
Arm Title
delefilcon A
Arm Type
Active Comparator
Arm Description
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
Arm Title
senofilcon A
Arm Type
Active Comparator
Arm Description
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
kalifilcon A
Intervention Description
kalifilcon A daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
delefilcon A
Intervention Description
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Primary Outcome Measure Information:
Title
Mean Change in logMAR Contact Lens Visual Acuity
Description
logMAR is the logarithm of the minim angle of resolution
Time Frame
Baseline, 2 Week Follow up
Title
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
Time Frame
2 Week Follow up
Title
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"
Time Frame
2 Week Follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent. myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye. correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye. free of any anterior segment disorders. adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks. access to internet connection and personal email to send/receive emails. habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses. Exclusion Criteria: participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation. have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months. have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study. using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses. refractive astigmatism of greater than 0.75 D in either eye. anisometropia (spherical equivalent) of greater than 2.00 D. amblyopic. have had any corneal surgery (e.g., refractive surgery).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Steffen
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 433
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Bausch Site 431
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Bausch Site 406
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Bausch Site 430
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Bausch Site 419
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Bausch Site 435
City
San Francisco
State/Province
California
ZIP/Postal Code
94112
Country
United States
Facility Name
Bausch Site 432
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94087
Country
United States
Facility Name
Bausch Site 409
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Bausch Site 416
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Bausch Site 415
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Bausch Site 434
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Bausch Site 405
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Bausch Site 412
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035
Country
United States
Facility Name
Bausch Site 401
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Bausch Site 437
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Bausch Site 414
City
Leavenworth
State/Province
Kansas
ZIP/Postal Code
66048
Country
United States
Facility Name
Bausch Site 413
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Bausch Site 421
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
Bausch Site 429
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55436
Country
United States
Facility Name
Bausch Site 422
City
Raytown
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Bausch Site 407
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Facility Name
Bausch Site 418
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States
Facility Name
Bausch Site 424
City
Jamestown
State/Province
New York
ZIP/Postal Code
14701
Country
United States
Facility Name
Bausch Site 403
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Bausch Site 417
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Bausch Site 411
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Bausch Site 423
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
Facility Name
Bausch Site 425
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Bausch Site 428
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97526
Country
United States
Facility Name
Bausch Site 420
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Bausch Site 427
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Bausch 410
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Bausch Site 408
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
33119
Country
United States
Facility Name
Bausch Site 404
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Bausch Site 426
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Product Performance of a New Silicone Hydrogel Contact Lens

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