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Clinical Evaluation of Two Daily Disposable Contact Lenses

Primary Purpose

Refractive Error

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

About this trial

This is an interventional treatment trial for Refractive Error

Eligibility Criteria

21 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be between 21 and 39 years of age.
  • Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
  • Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
  • Require a visual correction in both eyes (monovision allowed but no monofit).
  • Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
  • Astigmatism of 1.00D or less in both eyes.
  • Be able to wear the lens powers available for this study.
  • Be correctable to a visual acuity of 20/30 or better in each eye.

  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    • No amblyopia.
    • No evidence of lid abnormality or infection.
    • No conjunctival abnormality or infection.
    • No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
    • No other active ocular disease.

Exclusion Criteria:

  • Requires concurrent ocular medication.
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Diabetic.
  • Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • Extended lens wear in last 3 months.
  • PMMA or RGP lens wear in the previous 8 weeks.
  • Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
  • Abnormal lacrimal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial or in last 60 days."

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

etafilcon A / ocufilcon D

oculfilcon D / etafilcon A

ocufilcon D / ocufilcon D

etafilcon A / etafilcon A

Arm Description

etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable

ocufilcon D contact lens worn first, etafilcon A contact lens worn second

ocufilcon D contact lens worn first and second

etafilcon A contact lens worn first and second

Outcomes

Primary Outcome Measures

Lens Comfort
Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)

Secondary Outcome Measures

Comfort Throughout the Whole Day
Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".

Full Information

First Posted
September 29, 2008
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Singapore Polytechnic University, Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01163760
Brief Title
Clinical Evaluation of Two Daily Disposable Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Singapore Polytechnic University, Visioncare Research Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks 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
Refractive Error

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
etafilcon A / ocufilcon D
Arm Type
Other
Arm Description
etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable
Arm Title
oculfilcon D / etafilcon A
Arm Type
Other
Arm Description
ocufilcon D contact lens worn first, etafilcon A contact lens worn second
Arm Title
ocufilcon D / ocufilcon D
Arm Type
Other
Arm Description
ocufilcon D contact lens worn first and second
Arm Title
etafilcon A / etafilcon A
Arm Type
Other
Arm Description
etafilcon A contact lens worn first and second
Intervention Type
Device
Intervention Name(s)
etafilcon A
Intervention Description
daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
ocufilcon D
Intervention Description
daily disposable contact lens
Primary Outcome Measure Information:
Title
Lens Comfort
Description
Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)
Time Frame
1-week follow-up
Secondary Outcome Measure Information:
Title
Comfort Throughout the Whole Day
Description
Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
Time Frame
1-week follow-up
Other Pre-specified Outcome Measures:
Title
Comfort While Working on Computer
Description
Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
Time Frame
1-week-follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be between 21 and 39 years of age. Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space. Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). Require a visual correction in both eyes (monovision allowed but no monofit). Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes. Astigmatism of 1.00D or less in both eyes. Be able to wear the lens powers available for this study. Be correctable to a visual acuity of 20/30 or better in each eye. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No amblyopia. No evidence of lid abnormality or infection. No conjunctival abnormality or infection. No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities). No other active ocular disease. Exclusion Criteria: Requires concurrent ocular medication. Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear. Diabetic. Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). Extended lens wear in last 3 months. PMMA or RGP lens wear in the previous 8 weeks. Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study. Abnormal lacrimal secretions. Pre-existing ocular irritation that would preclude contact lens fitting. Keratoconus or other corneal irregularity. Pregnancy, lactating or planning a pregnancy at the time of enrollment. Participation in any concurrent clinical trial or in last 60 days."
Facility Information:
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of Two Daily Disposable Contact Lenses

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