Back to resultsMucin Balls and Corneal Inflammation Events
Primary Purpose
Corneal Inflammation, Corneal Infiltrative Events
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lotrafilcon A
comfilcon A
balafilcon A
etafilcon A
Sponsored by
About this trial
This is an interventional diagnostic trial for Corneal Inflammation
Eligibility Criteria
Inclusion Criteria:
- At least 18 years
- Free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis (via a large, >1mm central deep stromal scar) are not allowed. However, evidence of past Contact Lens-Induces Peripheral Ulcer (CLPU) will be allowed so long as no more then three such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the subject for a subsequent Corneal Infiltrate Event (CIE).
- Correctable vision to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
- Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively.
- Own or agree to purchase a pair of spectacles that can be worn when lenses are removed or in cases of ocular discomfort or emergency.
- Correctable vision to 20/30 or better at distance with dispensed contact lenses.
Exclusion Criteria:
- Use/wear of rigid gas permeable lenses within the last 30 days or Poly (methyl methacrylate) (PMMA) lenses within the last 3 months.
- Immunocompromising disease or insulin dependent diabetes or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during extended wear.
- Chronic use of systemic corticosteroids (with the exception of corticosteroid inhalers) or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
- Ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
- Use of any ocular medications in the last 2 weeks.
- Less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.
- Currently pregnant or lactating.
- Smoker
- Swimming routine of more than twice per month.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
lotrafilcon A, comfilcon A
lotrafilcon A, balafilcon A
Arm Description
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
Outcomes
Primary Outcome Measures
Corneal Infiltrate Events - Phase I
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Corneal Infiltrate Event- Phase II
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Secondary Outcome Measures
Full Information
NCT ID
NCT01437319
First Posted
September 16, 2011
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01437319
Brief Title
Mucin Balls and Corneal Inflammation Events
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Inflammation, Corneal Infiltrative Events
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lotrafilcon A, comfilcon A
Arm Type
Active Comparator
Arm Description
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
Arm Title
lotrafilcon A, balafilcon A
Arm Type
Active Comparator
Arm Description
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
Intervention Type
Device
Intervention Name(s)
lotrafilcon A
Intervention Description
To be used during run-in phase only.
Intervention Type
Device
Intervention Name(s)
comfilcon A
Intervention Description
To be assigned at randomization at phase 2 only.
Intervention Type
Device
Intervention Name(s)
balafilcon A
Intervention Description
To be assigned at randomization during phase 2 only.
Intervention Type
Other
Intervention Name(s)
etafilcon A
Intervention Description
Assigned to Neophytes during Phase I for a 2-week period
Primary Outcome Measure Information:
Title
Corneal Infiltrate Events - Phase I
Description
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Time Frame
1-Month Follow-up
Title
Corneal Infiltrate Event- Phase II
Description
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Time Frame
12-Month Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years
Free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis (via a large, >1mm central deep stromal scar) are not allowed. However, evidence of past Contact Lens-Induces Peripheral Ulcer (CLPU) will be allowed so long as no more then three such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the subject for a subsequent Corneal Infiltrate Event (CIE).
Correctable vision to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively.
Own or agree to purchase a pair of spectacles that can be worn when lenses are removed or in cases of ocular discomfort or emergency.
Correctable vision to 20/30 or better at distance with dispensed contact lenses.
Exclusion Criteria:
Use/wear of rigid gas permeable lenses within the last 30 days or Poly (methyl methacrylate) (PMMA) lenses within the last 3 months.
Immunocompromising disease or insulin dependent diabetes or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during extended wear.
Chronic use of systemic corticosteroids (with the exception of corticosteroid inhalers) or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
Ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
Use of any ocular medications in the last 2 weeks.
Less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.
Currently pregnant or lactating.
Smoker
Swimming routine of more than twice per month.
Facility Information:
City
Beachwood
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28195933
Citation
Szczotka-Flynn LB, Jiang Y, Stiegemeier MJ, Mutti DO, Walline J, Wilson T, Debanne S; Mucin Ball Study Group. Mucin Balls Influence Corneal Infiltrative Events. Optom Vis Sci. 2017 Apr;94(4):448-457. doi: 10.1097/OPX.0000000000001045.
Results Reference
derived
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Mucin Balls and Corneal Inflammation Events
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