Product Performance of a Toric Contact Lens

NCT ID: NCT00658996

Last Updated: 2011-12-12

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

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

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Product performance of a Bausch \& Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens

Detailed Description

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Conditions

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Myopia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SofLens DD Toric

Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens

Group Type EXPERIMENTAL

SofLens DD Toric

Intervention Type DEVICE

daily disposable wear contact lens for 2 weeks

Ciba Vision Toric Lens

Ciba Vision Focus Dailies Toric Contact Lens

Group Type ACTIVE_COMPARATOR

Ciba Vision Focus Dailies Toric Contact Lens

Intervention Type DEVICE

daily disposable wear contact lens for 2 weeks

Interventions

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SofLens DD Toric

daily disposable wear contact lens for 2 weeks

Intervention Type DEVICE

Ciba Vision Focus Dailies Toric Contact Lens

daily disposable wear contact lens for 2 weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
* Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
* Clear central cornea

Exclusion Criteria

* Systemic disease affecting ocular health
* Using systemic or topical medications
* Wears monovision or multifocal contact lenses
* Any grade 2 or greater slit lamp findings
* Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
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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Gerard Cairns, PhD,MCOptom

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Benny Chian, MCOptom,DO

Role: PRINCIPAL_INVESTIGATOR

Laser Focus Sdn Bhd, Vision Correction Centre

Locations

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Laser Focus Sdn Bhd, Vision Correction Centre

Johor Bahru, , Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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559

Identifier Type: -

Identifier Source: org_study_id