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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo 1 | Placebo Comparator | 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. |
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| Renu | Active Comparator | 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. |
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| Optifree | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear Care | Drug | neutralized Clear Care |
|
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| Measure | Description | Time Frame |
|---|---|---|
| HRT Corneal Scan | Looking for cell density | baseline and 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine W Sindt, O.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Contact Lens Clinic | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18441297 | Background | 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. | |
| 18362649 | Background | 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. |
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There is no plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non Contact Wearer Using Clear Care | neutralized Clear Care and no contact lens wear Clear Care: neutralized Clear Care |
| FG001 | Overnight Soaking With Renu | ReNu with and without sodium fluorescein ReNu MultiPlus MPS: overnight soak in solution |
| FG002 | Overnight Soak in Optifree | RepleniSH with and without sodium fluorescein ReNu MultiPlus MPS: overnight soak in solution OPTI-FREE RepleniSH MPDS: overnight soak in solution |
| FG003 | Overnight Soak in Optifree Replnish | ReNu and RepleniSH OPTI-FREE RepleniSH MPDS: overnight soak in solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non Contact Lens Wearers Using Clear Care | neutralized Clear Care and no contact lens wear Clear Care: neutralized Clear Care |
| BG001 | Overnight Soaking With Renu | ReNu with and without sodium fluorescein ReNu MultiPlus MPS: overnight soak in solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HRT Corneal Scan | Looking for cell density | Posted | Mean | Standard Deviation | cells/mm^3 | baseline and 2 hours |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non Contact Wearing Using Clear Care | neutralized Clear Care and no contact lens wear Clear Care: neutralized Clear Care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine W. Sindt | University of Iowa | 319-356-2916 | christine-sindt@uiowa.edu |
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|
| ReNu | Drug | overnight soak in solution |
|
| OPTI-FREE | Drug | overnight soak in solution |
|
|
| 17975422 | Background | 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. |
| 17993827 | Background | 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. |
| 17667609 | Background | 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. |
| 17498998 | Background | 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. |
| 17198013 | Background | 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. |
| 16974154 | Background | 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. |
| 16911987 | Background | 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. |
| 15448495 | Background | 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. |
| 11923239 | Background | 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. |
| BG002 | Overnight Soaking in Optifree | RepleniSH with and without sodium fluorescein ReNu MultiPlus MPS: overnight soak in solution OPTI-FREE RepleniSH MPDS: overnight soak in solution |
| BG003 | Overnight Soaking in Optifree Replinish | ReNu and RepleniSH OPTI-FREE RepleniSH MPDS: overnight soak in solution |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG003 | Overnight Soaking in Optifree Replinish | ReNu and RepleniSH OPTI-FREE RepleniSH MPDS: overnight soak in solution |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Overnight Soaking With Renu | ReNu with and without sodium fluorescein ReNu MultiPlus MPS: overnight soak in solution | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Overnight Soaking in Optifree | RepleniSH with and without sodium fluorescein ReNu MultiPlus MPS: overnight soak in solution OPTI-FREE RepleniSH MPDS: overnight soak in solution | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Overnight Soaking in Optifree Replinish | ReNu and RepleniSH OPTI-FREE RepleniSH MPDS: overnight soak in solution | 0 | 10 | 0 | 10 | 0 | 10 |
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