Mucin Balls and Corneal Inflammation Events
1 other identifier
interventional
289
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2011
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 16, 2011
CompletedFirst Posted
Study publicly available on registry
September 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
February 25, 2016
CompletedJune 19, 2018
January 1, 2016
2.4 years
September 16, 2011
November 16, 2015
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Corneal Infiltrate Events - Phase I
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
1-Month Follow-up
Corneal Infiltrate Event- Phase II
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
12-Month Follow-up
Study Arms (2)
lotrafilcon A, comfilcon A
ACTIVE COMPARATORAll 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.
lotrafilcon A, balafilcon A
ACTIVE COMPARATORAll 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.
Interventions
To be used during run-in phase only.
Assigned to Neophytes during Phase I for a 2-week period
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Beachwood, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Related Publications (1)
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.
PMID: 28195933DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tawnya Wilson, OD Principal Research Optometrist
- Organization
- Johnson &Johnson Vision Care, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
September 20, 2011
Study Start
September 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
June 19, 2018
Results First Posted
February 25, 2016
Record last verified: 2016-01