Polymorphonuclear Leukocyte Response During Overnight Lens Wear
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
Study Overview
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.
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
Time Frame: Week 1, 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.
Leukocyte Population
Time Frame: 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 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.
Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
Time Frame: 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. 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.
Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
Time Frame: 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. 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).
Change From Week 1 in Leukocyte Population at Week 5
Time Frame: Week 1, 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.
Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
Time Frame: Week 1, 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.
Secondary Outcomes
No secondary outcomes reported