Evaluation of the Performance of Non-molded Soft Contact Lenses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-12-31

Brief Summary

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To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.

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Detailed Description

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To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.

Conditions

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Ametropia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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soft contact lens

Group Type EXPERIMENTAL

Soft contact lens

Intervention Type DEVICE

Soft contact lens

non-lens wear

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Soft contact lens

Intervention Type DEVICE

Other Intervention Names

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Custom O2Optix

Eligibility Criteria

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Inclusion Criteria

* Male or female, good health, age \>17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood \& signed consent form.

Exclusion Criteria

* Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes