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

NCT01379768 | Completed Results

• 1 other identifier: P-373-C-102
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Blood Cells

Outcome Measures

Primary Outcomes (6)

• Leukocyte Population

  A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.

  Week 5

• Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)

  A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.

  Week 5

• Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)

  A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).

  Week 5

• Change From Week 1 in Leukocyte Population at Week 5

  A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.

  Week 1, Week 5

• Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5

  A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.

  Week 1, Week 5

• Change From Week 1 in Relative Oxidative Response of PMNs at Week 5

  A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.

  Week 1, Week 5

Study Arms (3)

Lotrafilcon A

ACTIVE COMPARATOR

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.

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

Lotrafilcon B

ACTIVE COMPARATOR

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.

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

No lens wear

NO INTERVENTION

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.

Interventions

Lotrafilcon A contact lens DEVICE

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.

Also known as: AIR OPTIX NIGHT & DAY AQUA

Lotrafilcon A

Lotrafilcon B contact lens DEVICE

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.

Also known as: NIGHT & DAY®

Lotrafilcon B

Clear Care Cleaning and Disinfection Solution DEVICE

Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses

Also known as: Clear Care®

Lotrafilcon A; Lotrafilcon B

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIBA VISION: lead
• University of Waterloo: collaborator

Study Sites (1)

University of Waterloo Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

Results Point of Contact

• Title: Director of Alcon Clinical, Atlanta
• Organization: Alcon Research

1-800-241-7629

Study Officials

• Lyndon Jones, PhD FCOptom FAAO, Director

  Centre for Contact Lens Research, School of Optometry, University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 23, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 8, 2013
• Results First Posted: March 8, 2013

Record last verified: 2013-03

Locations

CA (1)