Clinical trial NCT00804999: Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
Official title: Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Contact Lens Wear
Keywords: confocal microscopy
contact lens wear
contact lens solutions
sodium fluorescein
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2008-12-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HRT Corneal Scan
timeFrame: baseline and 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Contact Lens Clinic
state: Iowa
Study officials:
affiliation: University of Iowa
name: Christine W Sindt, O.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.