Mucin Balls and Corneal Inflammation Events

Phase 1

Completed

• Conditions: Corneal Infiltrative Events; Corneal Inflammation
• Interventions: Device: lotrafilcon A; Device: comfilcon A; Device: balafilcon A; Other: etafilcon A

• Registration Number: NCT01437319
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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 contact lens wear.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-11-16
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-28
• Results First Posted: 2016-02-25
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lotrafilcon A, comfilcon A	etafilcon A	All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
lotrafilcon A, comfilcon A	comfilcon A	All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
lotrafilcon A, balafilcon A	lotrafilcon A	All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
lotrafilcon A, comfilcon A	lotrafilcon A	All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
lotrafilcon A, balafilcon A	etafilcon A	All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
lotrafilcon A, balafilcon A	balafilcon A	All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.

Primary Outcome Measures

Name	Time	Method
Corneal Infiltrate Event- Phase II	12-Month Follow-up	The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Corneal Infiltrate Events - Phase I	1-Month Follow-up	The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.