One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens

NCT ID: NCT00902850

Last Updated: 2015-03-02

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

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-11-30

Brief Summary

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The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SofLens Daily Disposable

SofLens Daily Disposable Lenses

Group Type EXPERIMENTAL

SofLens Daily Disposable

Intervention Type DEVICE

Lenses to be worn for 8-16 hours

Marketed 1 Day Contact Lens

Marketed 1 Day Contact Lens

Group Type ACTIVE_COMPARATOR

Marketed 1 Day Contact Lens

Intervention Type DEVICE

Lenses to be worn for 8-16 hours

Interventions

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SofLens Daily Disposable

Lenses to be worn for 8-16 hours

Intervention Type DEVICE

Marketed 1 Day Contact Lens

Lenses to be worn for 8-16 hours

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Have no active ocular disease or allergic conjunctivitis.
* Not be using any topical ocular medications.

Exclusion Criteria

* Participating in a conflicting study.
* Considered by the Investigator to not be a suitable candidate for participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Steffen, OD, MS

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb Research Clinic

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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ROC2-08-169

Identifier Type: -

Identifier Source: org_study_id

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