Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear (CORNWALL)

Ciba Vision

Status: Completed

Conditions: White Blood Cells

Treatments: Device: Clear Care Cleaning and Disinfection Solution; Device: Lotrafilcon B contact lens; Device: Lotrafilcon A contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01379768

P-373-C-102

Details and patient eligibility

About

The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep. The results from contact lens wearers were compared with the results from non-contact lens wearers.

Full description

The objective of the study was to determine and compare the relative oxidative response of polymorphonuclear neutrophils (PMNs), the relative cell adhesion response of PMNs, and the leukocyte population in tear samples collected from contact lens wearers and non-contact lens wearers. Tear samples were collected via a binocular eye-wash. The samples were processed, and a cell count was performed using a hemacytometer. Flow cytometry was used to determine the expression of different PMN cell markers before and after stimulation with bacterial lipopolysaccharide (LPS).

Enrollment: 65 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 17 years of age or older.

• Ocular examination in the last two years.

• Has up-to-date spectacles.

• Falls into one of the following three categories:

  • Adapted wearer of Lotrafilcon A contact lenses
  • Adapted wearer of Lotrafilcon B contact lenses
  • Does not wear contact lenses

• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Ocular disease
• Systemic or topical medications that may affect ocular health.
• Known sensitivity to diagnostic pharmaceuticals used in study.
• Uses artificial tears and/or rewetting drops.
• Wears contact lenses on an overnight basis for more than one night per week.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups

Lotrafilcon A

Active Comparator group

Description:

Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.

Treatment:

Device: Lotrafilcon A contact lens

Device: Clear Care Cleaning and Disinfection Solution

Lotrafilcon B

Active Comparator group

Description:

Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.

Treatment:

Device: Lotrafilcon B contact lens

Device: Clear Care Cleaning and Disinfection Solution

No lens wear

No Intervention group

Description:

No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.