Mucin Balls and Corneal Inflammation Events
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/21/2018 |
Start Date: | September 2011 |
End Date: | February 2014 |
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.
protection from inflammatory events to the cornea and if mucin balls play a role in
protection during extended contact lens wear.
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.
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