Clinical trial NCT01437319: Mucin Balls and Corneal Inflammation Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Corneal Inflammation
Corneal Infiltrative Events
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Corneal Infiltrate Events - Phase I
timeFrame: 1-Month Follow-up
measure: Corneal Infiltrate Event- Phase II
timeFrame: 12-Month Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Beachwood
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
Study officials:
References:
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.