Phase 4
N=94
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
Myopia · Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01250925 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Corneal Epithelial Immune Dendritic Cell Density (Central Cornea) — 46.2; 44.8; 62.3 cells/mm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ReNu MultiPlus® MultiPurpose Solution (Drug); OPTI-FREE® RepleniSH® (Drug); Clear Care® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Epithelial Immune Dendritic Cell Density (Central Cornea) |
46.2; 44.8; 62.3 | — |
| PRIMARY Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea) |
109.0; 90.1; 113.6 | — |
| PRIMARY Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea) |
77.7; 67.8; 73.6 | — |
| PRIMARY Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea) |
106.1; 92.5; 106.1 | — |
| PRIMARY Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea) |
63.2; 59.0; 58.7 | — |
| PRIMARY Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea) |
0.3; 0.4; 0.4 | — |
| PRIMARY Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea) |
0.4; 0.5; 0.7 | — |
| PRIMARY Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea) |
1.6; 1.2; 1.1 | — |
| PRIMARY Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea) |
0.2; 0.6; 0.3 | — |
| PRIMARY Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea) |
0.4; 0.7; 0.8 | — |
| SECONDARY Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events |
0; 1; 1 | — |
Summary
The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.
Eligibility Criteria
Inclusion Criteria
- Subjects must be 18 years of age and may be of any race and either gender.
- Subjects must not have ever worn contact lenses.
- Subjects must have normal, healthy eyes.
Exclusion Criteria
- Subjects must not use additional lens cleaners.
- subjects must not have any ocular or systemic disease.
- Subjects must not have history of ocular surgery/trauma within the last 6 months.
Data sourced from ClinicalTrials.gov (NCT01250925). 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.