Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure

NCT00804999 | Completed Results

• 1 other identifier: 200806729
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Contact Lens Wear

Keywords

confocal microscopy; contact lens wear; contact lens solutions; sodium fluorescein

Outcome Measures

Primary Outcomes (1)

• HRT Corneal Scan

  Looking for cell density

  baseline and 2 hours

Study Arms (3)

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.

Drug: Clear Care

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.

Drug: ReNu

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.

Drug: OPTI-FREE

Interventions

Clear Care DRUG

neutralized Clear Care

Also known as: hydrogen peroxide disinfecting solution

Placebo 1

ReNu DRUG

overnight soak in solution

Renu

OPTI-FREE DRUG

overnight soak in solution

Also known as: Replenish

Optifree

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vision correctable to 20/30 or better in both eyes
• Successful soft contact lens wear for at least 2 weeks prior to enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Christine Sindt: lead
• Alcon Research: collaborator

Study Sites (1)

University of Iowa Contact Lens Clinic

Iowa City, Iowa, 52242, United States

Location

Related Publications (11)

• 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.

  PMID: 18441297 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.

  PMID: 18362649 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.

  PMID: 17975422 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.

  PMID: 17993827 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.

  PMID: 17667609 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.

  PMID: 17498998 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.

  PMID: 17198013 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.

  PMID: 16974154 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.

  PMID: 16911987 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.

  PMID: 15448495 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.

  PMID: 11923239 BACKGROUND

Results Point of Contact

• Title: Dr. Christine W. Sindt
• Organization: University of Iowa

christine-sindt@uiowa.edu

319-356-2916

Study Officials

• Christine W Sindt, O.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)