N/A N=51 Randomized Triple-blind Basic Science

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

Normal Contact Lens Wear

Bottom Line

View on ClinicalTrials.gov: NCT00804999 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcome: Primary: HRT Corneal Scan — 85; 66; 49; 63 cells/mm^3

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Clear Care (Drug); ReNu (Drug); OPTI-FREE (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Christine Sindt
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY HRT Corneal Scan	85; 66; 49; 63; 87; 65	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00804999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.