Clinical trial NCT01250925: Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
Official title: Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Refractive Error
Keywords: Contact lens
Lens care
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: Alcon Research
First posted: 2010-12-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be 18 years of age and may be of any race and either gender.
2. Subjects must not have ever worn contact lenses.
3. Subjects must have normal, healthy eyes.

Exclusion Criteria:

1. Subjects must not use additional lens cleaners.
2. subjects must not have any ocular or systemic disease.
3. Subjects must not have history of ocular surgery/trauma within the last 6 months.

Primary outcomes:
measure: Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)
timeFrame: Six weeks
measure: Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)
timeFrame: Six weeks
Secondary outcomes:
measure: Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events
timeFrame: Six weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Pedram Hamrah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Christine Sindt, OD
role: PRINCIPAL_INVESTIGATOR
References: