Mucin Balls and Corneal Inflammation Events

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Corneal Inflammation; Corneal Infiltrative Events

Treatments: Device: comfilcon A; Other: etafilcon A; Device: lotrafilcon A; Device: balafilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437319

CR-005016

Details and patient eligibility

About

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.

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 2 patient groups

lotrafilcon A, comfilcon A

Active Comparator group

Description:

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.

Treatment:

Other: etafilcon A

Device: lotrafilcon A

Device: comfilcon A

lotrafilcon A, balafilcon A

Active Comparator group

Description:

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.

Treatment:

Other: etafilcon A

Device: balafilcon A

Device: lotrafilcon A