Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
NCT ID: NCT00804999
Last Updated: 2018-01-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
51 participants
INTERVENTIONAL
2008-11-01
2009-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
NCT01250925
Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients
NCT00799422
Corneal and Conjunctival Sensitivity and Staining Study
NCT00455455
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
NCT00995189
Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
NCT01996709
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Clear Care
neutralized Clear Care
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.
ReNu
overnight soak in solution
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.
OPTI-FREE
overnight soak in solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clear Care
neutralized Clear Care
ReNu
overnight soak in solution
OPTI-FREE
overnight soak in solution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Successful soft contact lens wear for at least 2 weeks prior to enrollment
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alcon Research
INDUSTRY
Christine Sindt
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christine Sindt
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christine W Sindt, O.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa Contact Lens Clinic
Iowa City, Iowa, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200806729
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.