N/A
Completed N=65
Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear
White Blood Cells
Source: ClinicalTrials.gov NCT01379768 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Leukocyte Population — 583187; 420345; 738140 Leukocytes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leukocyte Population |
583187; 420345; 738140 | — |
| PRIMARY Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs) |
1.1; 1.2; 1.1 | — |
| PRIMARY Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs) |
1.2; 1.7; 1.3 | — |
| PRIMARY Change From Week 1 in Leukocyte Population at Week 5 |
-1377; -95301; 122316 | — |
| PRIMARY Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5 |
-0.01; 0.00; -0.01 | — |
| PRIMARY Change From Week 1 in Relative Oxidative Response of PMNs at Week 5 |
0.05; 0.24; -0.19 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01379768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.