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A 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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. They are of legal age (18 years) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
  5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
  6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
  7. They have successfully worn contact lenses within six months of starting the study. -

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They are aphakic.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  7. They are pregnant or lactating.
  8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
  10. They have diabetes.
  11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Sites / Locations

  • Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

etafilcon A first nelfilcon A second

nelfilcon A first, etafilcon A second

Arm Description

etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2

nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2

Outcomes

Primary Outcome Measures

Visual Acuity
Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.
Subjective Lens Comfort
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.

Secondary Outcome Measures

Subject-reported Overall Product Performance
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Optimum Lens Fit
Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.

Full Information

First Posted
December 21, 2007
Last Updated
May 5, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT00600080
Brief Title
A Comparison of Two Daily Disposable Contact Lenses
Official Title
The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.

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
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etafilcon A first nelfilcon A second
Arm Type
Other
Arm Description
etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2
Arm Title
nelfilcon A first, etafilcon A second
Arm Type
Other
Arm Description
nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2
Intervention Type
Device
Intervention Name(s)
etafilcon A
Other Intervention Name(s)
1-DAY ACUVUE MOIST
Intervention Description
contact lens worn daily for one week (first or second week depending on arm)
Intervention Type
Device
Intervention Name(s)
nelfilcon A
Other Intervention Name(s)
DAILIES AquaComfort Plus
Intervention Description
Contact lens worn daily for one week (first or second week depending on arm)
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.
Time Frame
2-week
Title
Subjective Lens Comfort
Description
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Time Frame
2-week
Secondary Outcome Measure Information:
Title
Subject-reported Overall Product Performance
Description
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Time Frame
2-week
Title
Optimum Lens Fit
Description
Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.
Time Frame
Baseline, 1-week, 2-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: They are of legal age (18 years) and capacity to volunteer. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC). They have successfully worn contact lenses within six months of starting the study. - Exclusion Criteria: They have an ocular disorder which would normally contra-indicate contact lens wear. They have a systemic disorder which would normally contra-indicate contact lens wear. They are using any topical medication such as eye drops or ointment. They are aphakic. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. They are pregnant or lactating. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV). They have diabetes. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Facility Information:
Facility Name
Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
City
Manchester
ZIP/Postal Code
M60 1QD
Country
United Kingdom

12. IPD Sharing Statement

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A Comparison of Two Daily Disposable Contact Lenses

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