Back to resultsDaytime Corneal Swelling During Wear of Narafilcon B Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
narafilcon B
Polymacon
Lotrafilcon A
Spectacles
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Be of legal age (i.e. ≥ 18 years).
- Be mentally competent, willing and able to sign a written informed consent form.
- Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
- Have spectacle astigmatism <1.25D in each eye.
- Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
- Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.
Exclusion Criteria:
- Required concurrent ocular medication.
- Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Eye injury or surgery within eight 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.
Sites / Locations
- Coles-Brennan Pty Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Active Comparator
Active Comparator
Arm Label
Spectacles No Lenses
narafilcon B
polymacon
lotrafilcon A
Arm Description
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Outcomes
Primary Outcome Measures
Corneal Thickness
Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.
Endothelial Blebs
Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).
Limbal Redness
Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.
Secondary Outcome Measures
Overall Comfort
Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).
Full Information
NCT ID
NCT01444287
First Posted
September 27, 2011
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01444287
Brief Title
Daytime Corneal Swelling During Wear of Narafilcon B Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (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 purpose of this research is to measure daytime open-eye response to wearing of narafilcon B 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spectacles No Lenses
Arm Type
Placebo Comparator
Arm Description
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Arm Title
narafilcon B
Arm Type
Experimental
Arm Description
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Arm Title
polymacon
Arm Type
Active Comparator
Arm Description
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Arm Title
lotrafilcon A
Arm Type
Active Comparator
Arm Description
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Intervention Type
Device
Intervention Name(s)
narafilcon B
Intervention Description
test product
Intervention Type
Device
Intervention Name(s)
Polymacon
Intervention Description
marketed product
Intervention Type
Device
Intervention Name(s)
Lotrafilcon A
Intervention Description
marketed product
Intervention Type
Other
Intervention Name(s)
Spectacles
Intervention Description
None - subject used own spectacles
Primary Outcome Measure Information:
Title
Corneal Thickness
Description
Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.
Time Frame
After 8 hours of contact lens wear
Title
Endothelial Blebs
Description
Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).
Time Frame
baseline, after 20 minutes of treatment conditions
Title
Limbal Redness
Description
Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.
Time Frame
Baseline, After 8 hours of treatment conditions
Secondary Outcome Measure Information:
Title
Overall Comfort
Description
Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).
Time Frame
after 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be of legal age (i.e. ≥ 18 years).
Be mentally competent, willing and able to sign a written informed consent form.
Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
Have spectacle astigmatism <1.25D in each eye.
Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.
Exclusion Criteria:
Required concurrent ocular medication.
Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Eye injury or surgery within eight 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Brennan, McOptom PhD
Organizational Affiliation
Coles-Brennan Pty Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coles-Brennan Pty Ltd
City
Hawthorn
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Daytime Corneal Swelling During Wear of Narafilcon B Lenses
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