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The Clinical Evaluation of Two Daily Disposable Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
etafilcon A
omafilcon 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:

  • 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 which have 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 worn soft 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 edema, corneal vascularization, 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 are currently taking part in any other clinical study or research.

Sites / Locations

  • Eurolens Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

etafilcon A/etafilcon A

etafilcon A/omafilcon A

omafilcon A/etafilcon A

omafilcon A/omafilcon A

Arm Description

Period 1: etafilcon A, Period 2: etafilcon A

Period 1: etafilcon A, Period 2: omafilcon A

Period 1: omafilcon A, Period 2: etafilcon A

Period 1: omafilcon A, Period 2: omafilcon A

Outcomes

Primary Outcome Measures

Distance Visual Acuity
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

Secondary Outcome Measures

Lens Comfort
A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable

Full Information

First Posted
September 26, 2008
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Eurolens Research
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1. Study Identification

Unique Protocol Identification Number
NCT00762996
Brief Title
The 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
August 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

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

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
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etafilcon A/etafilcon A
Arm Type
Active Comparator
Arm Description
Period 1: etafilcon A, Period 2: etafilcon A
Arm Title
etafilcon A/omafilcon A
Arm Type
Active Comparator
Arm Description
Period 1: etafilcon A, Period 2: omafilcon A
Arm Title
omafilcon A/etafilcon A
Arm Type
Active Comparator
Arm Description
Period 1: omafilcon A, Period 2: etafilcon A
Arm Title
omafilcon A/omafilcon A
Arm Type
Active Comparator
Arm Description
Period 1: omafilcon A, Period 2: omafilcon A
Intervention Type
Device
Intervention Name(s)
etafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
omafilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Distance Visual Acuity
Description
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Lens Comfort
Description
A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable
Time Frame
1 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 which have 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 worn soft 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 edema, corneal vascularization, 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 are currently taking part in any other clinical study or research.
Facility Information:
Facility Name
Eurolens Research
City
Manchester
ZIP/Postal Code
M60 1QD
Country
United Kingdom

12. IPD Sharing Statement

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The Clinical Evaluation of Two Daily Disposable Contact Lenses

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