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A Clinical Comparison of Two Daily Disposable Contact Lenses.

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
etafilcon A
nelfilcon A
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18 years to 45 years
  • Current daily soft contact lens as habitual optical correction:

  • Refraction:

    • Best sphere (corrected for back vertex distance) -1.00 to -6.00D
    • Cylinder 0.00 to - 0.75D
  • Best spectacle corrected visual acuity of 6/9 or better in each eye
  • Willingness to adhere to the instructions set in the clinical protocol
  • Signature of the subject on the informed consent form

Exclusion Criteria:

  • Systemic or ocular allergies which might interfere with contact lens wear
  • Systemic disease which might interfere with contact lens wear
  • Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
  • Use of medication which might interfere with contact lens wear
  • Active ocular infection
  • Use of ocular medication
  • Significant ocular anomaly
  • Presence of two or more corneal scars in either eye
  • Pregnancy or lactation
  • Any medical condition that might be prejudicial to the study
  • Participated in any other clinical studies in the past month
  • Currently wears monovision

Sites / Locations

  • Otometry Technology Group, Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

etafilcon A/nelfilcon A

nelfilcon A/etafilcon A

Arm Description

etafilcon A contact lens worn first and nelfilcon A contact lens worn second

nelfilcon A contact lens worn first and etafilcon A contact lens second.

Outcomes

Primary Outcome Measures

Overall Comfort
Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Secondary Outcome Measures

Inferior Region Corneal Staining
The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)
End of the Day Comfort
Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Initial Comfort
Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Overall Lens Handling
Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Full Information

First Posted
October 15, 2008
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00775021
Brief Title
A Clinical Comparison of Two Daily Disposable Contact Lenses.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the clinical performance of two daily disposable 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
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etafilcon A/nelfilcon A
Arm Type
Active Comparator
Arm Description
etafilcon A contact lens worn first and nelfilcon A contact lens worn second
Arm Title
nelfilcon A/etafilcon A
Arm Type
Active Comparator
Arm Description
nelfilcon A contact lens worn first and etafilcon A contact lens second.
Intervention Type
Device
Intervention Name(s)
etafilcon A
Intervention Description
Contact Lens
Intervention Type
Device
Intervention Name(s)
nelfilcon A
Intervention Description
Contact Lens
Primary Outcome Measure Information:
Title
Overall Comfort
Description
Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Inferior Region Corneal Staining
Description
The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)
Time Frame
1 week
Title
End of the Day Comfort
Description
Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame
1 week
Title
Initial Comfort
Description
Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame
1 Week
Title
Overall Lens Handling
Description
Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18 years to 45 years Current daily soft contact lens as habitual optical correction: Refraction: Best sphere (corrected for back vertex distance) -1.00 to -6.00D Cylinder 0.00 to - 0.75D Best spectacle corrected visual acuity of 6/9 or better in each eye Willingness to adhere to the instructions set in the clinical protocol Signature of the subject on the informed consent form Exclusion Criteria: Systemic or ocular allergies which might interfere with contact lens wear Systemic disease which might interfere with contact lens wear Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion) Use of medication which might interfere with contact lens wear Active ocular infection Use of ocular medication Significant ocular anomaly Presence of two or more corneal scars in either eye Pregnancy or lactation Any medical condition that might be prejudicial to the study Participated in any other clinical studies in the past month Currently wears monovision
Facility Information:
Facility Name
Otometry Technology Group, Ltd.
City
London
ZIP/Postal Code
SW1E 6AU
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Clinical Comparison of Two Daily Disposable Contact Lenses.

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