Mucin Balls and Corneal Inflammation Events

Corneal Infiltrative Events Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437319
• Other study ID #: CR-005016
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2011
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Infiltrative Events
• Corneal Inflammation
• Inflammation
• Keratitis

Intervention

Device:
• lotrafilcon A
To be used during run-in phase only.
• comfilcon A
To be assigned at randomization at phase 2 only.
• balafilcon A
To be assigned at randomization during phase 2 only.

Other:
• etafilcon A
Assigned to Neophytes during Phase I for a 2-week period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Infiltrate Events - Phase I	The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.	1-Month Follow-up
Primary	Corneal Infiltrate Event- Phase II	The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.	12-Month Follow-up