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

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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.


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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