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OpenTrials
Completed

NCT Number: NCT00804999

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

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.

Completed

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Key information

Conditions

Normal Contact Lens Wear

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Contact Lens Clinic

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clear Care

Drug

neutralized Clear Care

Other names: hydrogen peroxide disinfecting solution

ReNu

Drug

overnight soak in solution

OPTI-FREE

Drug

overnight soak in solution

Other names: Replenish

Primary outcomes

  1. HRT Corneal Scan

    Time frame: baseline and 2 hours

    Looking for cell density

Sponsors and collaborators

Lead sponsor

Christine Sindt

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 9, 2008
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.