Status:
COMPLETED
Mucin Balls and Corneal Inflammation Events
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Corneal Inflammation
Corneal Infiltrative Events
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT01437319
Start Date
September 1 2011
End Date
February 1 2014
Last Update
June 19 2018
Active Locations (3)
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1
Beachwood, Ohio, United States
2
Cleveland, Ohio, United States
3
Columbus, Ohio, United States