Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborators:
University of Iowa
Alcon Research
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01250925
First received: November 29, 2010
Last updated: April 10, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myopia Refractive Error |
Drug: ReNu MultiPlus® MultiPurpose Solution Drug: OPTI-FREE® RepleniSH® Drug: Clear Care® |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
| Official Title: | Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study |
Resource links provided by NLM:
Further study details as provided by Massachusetts Eye and Ear Infirmary:
Primary Outcome Measures:
- Corneal Epithelial Immune Status [ Time Frame: Six weeks ] [ Designated as safety issue: No ]The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells and immune cell morphology.
Secondary Outcome Measures:
- Safety Analysis [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: OPTI-FREE® RepleniSH®
33 participants will be assigned to use this lens care regimen during the six-week assessment period
|
Drug: OPTI-FREE® RepleniSH®
Contact Lens care regimen
|
|
Active Comparator: Clear Care®
33 participants will be assigned to use this lens care regimen during the six-week assessment period
|
Drug: Clear Care®
Contact lens care regimen
|
|
Active Comparator: ReNu MultiPlus® MultiPurpose Solution
33 participants will be assigned to use this lens care regimen during the six-week assessment period
|
Drug: ReNu MultiPlus® MultiPurpose Solution
Contact lens care regimen
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250925
Locations
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242-1091 | |
| United States, Massachusetts | |
| Massachusetts Eye and Ear Infirmary | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
University of Iowa
Alcon Research
Investigators
| Principal Investigator: | Pedram Hamrah, MD | Massachusetts Eye and Ear Infirmary |
| Principal Investigator: | Christine Sindt, OD | University of Iowa |
More Information
No publications provided
| Responsible Party: | Massachusetts Eye and Ear Infirmary |
| ClinicalTrials.gov Identifier: | NCT01250925 History of Changes |
| Other Study ID Numbers: | 10-04-029 |
| Study First Received: | November 29, 2010 |
| Last Updated: | April 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts Eye and Ear Infirmary:
|
Contact lens Lens care |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013