- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00804999
Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Several types of solutions are used in contact lens wear.
Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts.
The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to identify any potential consequences of contact lens wear and/or care solution used.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Contact Lens Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Vision correctable to 20/30 or better in both eyes
- Successful soft contact lens wear for at least 2 weeks prior to enrollment
Exclusion Criteria:
- History of hypersensitivity to any of the components in any of the lens solutions
- One functional eye or a monofit lens
- Any abnormal slit-lamp finding at baseline
- Use of topical ocular meds
- Any systemic condition with significant ocular side effects or that interfere with contact lens wear
- Enrollment of the investigator's office staff, relatives or members of their respective households
- Enrollment of more than one member of the same household
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo 1
Subjects that have never worn contacts with no ocular problems were selected.
A baseline HRT was performed.
Trial contact lenses were soaked in clear care solution for 10 hours.
After 10 hours of the lenses soaking in clear care the subject returned.
The contacts lenses that were soaked in clear care were inserted onto the patients eyes.
The patient then wore the contacts for two hours.
After two hours the contact lenses were removed.
An HRT was performed immediately after removing the contact lenses.
The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
|
neutralized Clear Care
Other Names:
|
Active Comparator: Renu
Subjects that had worn contacts for at least two weeks without incident were selected.
A baseline HRT was performed.Trial contacts lenses were soaked in ReNu contact solution for 10 hours.
After 10 hours of the lenses soaking in ReNu the subject returned.
The contacts were inserted onto the patients eyes.
The patient then wore the contacts for two hours.
After two hours the contacts lenses were removed.
An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
|
overnight soak in solution
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Active Comparator: Optifree
Subjects that had worn contacts for at least two weeks without incident were selected.
A baseline HRT was performed.Trial contacts lenses were soaked in Optifree Replenish contact solution for 10 hours.
After 10 hours of the lenses soaking in Optifree Replenish the subject returned.
The contacts were inserted onto the patients eyes.
The patient wore contacts the for two hours.
After two hours the contacts were removed.
An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
|
overnight soak in solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HRT Corneal Scan
Time Frame: baseline and 2 hours
|
Looking for cell density
|
baseline and 2 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine W Sindt, O.D., University of Iowa
Publications and helpful links
General Publications
- Patel DV, McGhee CN. In vivo laser scanning confocal microscopy confirms that the human corneal sub-basal nerve plexus is a highly dynamic structure. Invest Ophthalmol Vis Sci. 2008 Aug;49(8):3409-12. doi: 10.1167/iovs.08-1951. Epub 2008 Apr 25.
- Dosso AA, Rungger-Brandle E. Clinical course of epidemic keratoconjunctivitis: evaluation by in vivo confocal microscopy. Cornea. 2008 Apr;27(3):263-8. doi: 10.1097/ICO.0b013e31815b7d7d.
- Fonn D, Simpson T, Woods J, Woods C. New technologies to assess lens-mediated effects of the cornea. Eye Contact Lens. 2007 Nov;33(6 Pt 2):364-70; discussion 382. doi: 10.1097/ICL.0b013e318157c98f.
- Bantseev V, McCanna DJ, Driot JY, Ward KW, Sivak JG. Biocompatibility of contact lens solutions using confocal laser scanning microscopy and the in vitro bovine cornea. Eye Contact Lens. 2007 Nov;33(6 Pt 1):308-16. doi: 10.1097/ICL.0b013e31803c55ad.
- Kanavi MR, Javadi M, Yazdani S, Mirdehghanm S. Sensitivity and specificity of confocal scan in the diagnosis of infectious keratitis. Cornea. 2007 Aug;26(7):782-6. doi: 10.1097/ICO.0b013e318064582d.
- Efron N. Contact lens-induced changes in the anterior eye as observed in vivo with the confocal microscope. Prog Retin Eye Res. 2007 Jul;26(4):398-436. doi: 10.1016/j.preteyeres.2007.03.003. Epub 2007 Apr 1.
- Zhivov A, Stave J, Vollmar B, Guthoff R. In vivo confocal microscopic evaluation of langerhans cell density and distribution in the corneal epithelium of healthy volunteers and contact lens wearers. Cornea. 2007 Jan;26(1):47-54. doi: 10.1097/ICO.0b013e31802e3b55.
- Bastion ML, Mohamad MH. Study of the factors associated with the presence of white dots in the corneas of regular soft contact lens users from an Asian country. Eye Contact Lens. 2006 Sep;32(5):223-7. doi: 10.1097/01.icl.0000199891.35160.68.
- Su PY, Hu FR, Chen YM, Han JH, Chen WL. Dendritiform cells found in central cornea by in-vivo confocal microscopy in a patient with mixed bacterial keratitis. Ocul Immunol Inflamm. 2006 Aug;14(4):241-4. doi: 10.1080/09273940600732398.
- Nguyen TH, Dudek LT, Krisciunas TC, Matiaco P, Planck SR, Mathers WD, Rosenbaum JT. In vivo confocal microscopy: increased conjunctival or episcleral leukocyte adhesion in patients who wear contact lenses with lower oxygen permeability (Dk) values. Cornea. 2004 Oct;23(7):695-700. doi: 10.1097/01.ico.0000127482.00843.c8.
- Patel SV, McLaren JW, Hodge DO, Bourne WM. Confocal microscopy in vivo in corneas of long-term contact lens wearers. Invest Ophthalmol Vis Sci. 2002 Apr;43(4):995-1003.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200806729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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