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

Christine Sindt

Status: Completed

Conditions: Normal Contact Lens Wear

Treatments: Drug: ReNu; Drug: Clear Care; Drug: OPTI-FREE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00804999

200806729

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 3 patient groups, including a placebo group

Placebo 1

Placebo Comparator group

Description:

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.

Treatment:

Drug: Clear Care

Renu

Active Comparator group

Description:

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.

Treatment:

Drug: ReNu

Optifree

Active Comparator group

Description:

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.

Treatment:

Drug: OPTI-FREE