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Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

NCT ID: NCT00810511

Last Updated: 2023-12-05

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

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.

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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Lotrafilcon A

Investigational, spherical, silicone hydrogel contact lenses

Group Type EXPERIMENTAL

Lotrafilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens

Comfilcon A

Commercially marketed, spherical, silicone hydrogel contact lenses

Group Type ACTIVE_COMPARATOR

Comfilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens

Interventions

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Lotrafilcon A contact lens

Silicone hydrogel contact lens

Intervention Type DEVICE

Comfilcon A contact lens

Silicone hydrogel contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
* Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
* Replace lenses on a weekly or longer schedule

Exclusion Criteria

* Requires concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
* Current soft toric lens wearers
* Those who dispose of their soft lenses on a daily basis
* Current NIGHT \& DAY® or Biofinity® lens wearers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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P-335-C-007

Identifier Type: -

Identifier Source: org_study_id