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Clinical Study of Approved Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Senofilcon C
Samfilcon 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 - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent.
  2. Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
  3. Subjects must be willing and able to comply with all treatment and follow-up/study procedures.
  4. Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
  5. Subjects must have clear central corneas and be free of any anterior segment disorders.
  6. Subjects must be myopic and require contact lens sphere power correction from -0.50 diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes).
  7. Subjects must be habitual wearers of Johnson & Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye.
  8. Subjects must use a contact lens care regimen on a routine basis.
  9. Subjects must agree to wear their study lenses on a daily wear basis for the duration

Exclusion Criteria:

  1. Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation

  2. Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:

    • she is currently pregnant
    • she plans to become pregnant during the study
    • she is breastfeeding
  3. Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
  4. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

Sites / Locations

  • valeant Site 02
  • Valeant Site 03
  • Valeant Site 04
  • Valeant Site 06
  • Valeant Site 01
  • Valeant Site 05
  • Valeant Site 07
  • Valeant Site 08
  • Valeant Site 09
  • Valeant Site 10
  • Valeant Site 11

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Senofilcon C

Samfilcon A

Arm Description

Senofilcon C Contact Lens

Samfilcon A Contact Lens

Outcomes

Primary Outcome Measures

End of Day Comfort
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.
Overall Vision
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2017
Last Updated
January 6, 2021
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03351101
Brief Title
Clinical Study of Approved Contact Lenses
Official Title
Clinical Study of Approved Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
December 8, 2017 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of Johnson & Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses
Detailed Description
to compare the performance of currently marketed Johnson & Johnson Acuvue Vita (senofilcon C) soft contact lenses to the currently marketed Bausch + Lomb Ultra (samfilcon A) soft contact lenses among adapted wearers of Acuvue Oasys soft contact lenses.

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
Model Description
randomized, bilateral, d o u b l e - masked, 1-month study with two parallel groups
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Senofilcon C
Arm Type
Experimental
Arm Description
Senofilcon C Contact Lens
Arm Title
Samfilcon A
Arm Type
Experimental
Arm Description
Samfilcon A Contact Lens
Intervention Type
Device
Intervention Name(s)
Senofilcon C
Intervention Description
Senofilcon C Contact Lens
Intervention Type
Device
Intervention Name(s)
Samfilcon A
Intervention Description
Samfilcon A Contact Lens
Primary Outcome Measure Information:
Title
End of Day Comfort
Description
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.
Time Frame
1 month
Title
Overall Vision
Description
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent. Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations. Subjects must be willing and able to comply with all treatment and follow-up/study procedures. Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. Subjects must have clear central corneas and be free of any anterior segment disorders. Subjects must be myopic and require contact lens sphere power correction from -0.50 diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes). Subjects must be habitual wearers of Johnson & Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye. Subjects must use a contact lens care regimen on a routine basis. Subjects must agree to wear their study lenses on a daily wear basis for the duration Exclusion Criteria: Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant she plans to become pregnant during the study she is breastfeeding Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Facility Information:
Facility Name
valeant Site 02
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Valeant Site 03
City
San Francisco
State/Province
California
ZIP/Postal Code
94112
Country
United States
Facility Name
Valeant Site 04
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Valeant Site 06
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Valeant Site 01
City
Orlando
State/Province
Florida
ZIP/Postal Code
32812
Country
United States
Facility Name
Valeant Site 05
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Valeant Site 07
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Valeant Site 08
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States
Facility Name
Valeant Site 09
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Valeant Site 10
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Valeant Site 11
City
New Berlin
State/Province
Wisconsin
ZIP/Postal Code
53151
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical Study of Approved Contact Lenses

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