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Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses

Primary Purpose

Vision Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JJVC Marketed Contact Lens (Test)
Competitor Marketed Contact Lens (Control)
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vision Disorders

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be between (and including) 18 and 39 years of age.
  • The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
  • The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye.
  • The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

  • Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Any autoimmune disease or use of medication, which may interfere with contact lens wear.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
  • Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Monovision, multi-focal, toric, or extended wear contact lens correction.
  • Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  • History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
  • Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

Sites / Locations

  • Becky Bizzle, OD
  • Complete Family Eye Care of Fruit Cove
  • Golden Family Eyecare
  • St. Lucy's Vision Center
  • Eye Associates of Winter Park
  • VisualEyes, Inc.
  • Advantage Eyecare Associates, LLC
  • Sacco Eye Group
  • Advanced Family Eye Care
  • total Eye Care PA
  • Brian Frazier, OD
  • Timothy R. Poling, OD
  • Ziegler Leffingwell Eyecare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sequence 1: Test Control Test

Sequence 2: Control Test Control

Arm Description

Test/control/test using the Johnson & Johnson Vision Care (JJVC) Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each in between lenses for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn.

Control/test/control using the JJVC Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn.

Outcomes

Primary Outcome Measures

Overall Comfort
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2015
Last Updated
June 13, 2017
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02595502
Brief Title
Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
November 1, 2015 (Actual)
Study Completion Date
November 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1: Test Control Test
Arm Type
Active Comparator
Arm Description
Test/control/test using the Johnson & Johnson Vision Care (JJVC) Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each in between lenses for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn.
Arm Title
Sequence 2: Control Test Control
Arm Type
Active Comparator
Arm Description
Control/test/control using the JJVC Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn.
Intervention Type
Device
Intervention Name(s)
JJVC Marketed Contact Lens (Test)
Other Intervention Name(s)
senofilcon A
Intervention Type
Device
Intervention Name(s)
Competitor Marketed Contact Lens (Control)
Other Intervention Name(s)
delefilcon A
Primary Outcome Measure Information:
Title
Overall Comfort
Description
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.
Time Frame
1 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be between (and including) 18 and 39 years of age. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study. The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye. The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye. The subject must have best corrected visual acuity of 20/25 or better in each eye. Exclusion Criteria: Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued). Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.). Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Monovision, multi-focal, toric, or extended wear contact lens correction. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
Facility Information:
Facility Name
Becky Bizzle, OD
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Complete Family Eye Care of Fruit Cove
City
Fruit Cove
State/Province
Florida
ZIP/Postal Code
32259
Country
United States
Facility Name
Golden Family Eyecare
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
St. Lucy's Vision Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33625
Country
United States
Facility Name
Eye Associates of Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
VisualEyes, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Advantage Eyecare Associates, LLC
City
Neodesha
State/Province
Kansas
ZIP/Postal Code
66757
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Advanced Family Eye Care
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Facility Name
total Eye Care PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Brian Frazier, OD
City
Jacksonville
State/Province
Texas
ZIP/Postal Code
17576
Country
United States
Facility Name
Timothy R. Poling, OD
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Ziegler Leffingwell Eyecare
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses

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