Phase 2
N=282
Mucin Balls and Corneal Inflammation Events
Corneal Inflammation · Corneal Infiltrative Events
Bottom Line
View on ClinicalTrials.gov: NCT01437319 ↗Enrolled (actual)
282
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Corneal Infiltrate Events - Phase I — 18.6; 5.7 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lotrafilcon A (Device); comfilcon A (Device); balafilcon A (Device); etafilcon A (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Infiltrate Events - Phase I |
18.6; 5.7 | — |
| PRIMARY Corneal Infiltrate Event- Phase II |
4.5; 3.6; 14.9; 33.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01437319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.