Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

NCT ID: NCT01055132

Last Updated: 2018-06-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nelfilcon A toric/ Etafilcon A toric

Nelfilcon A toric contact lens first, then etafilcon A toric toric second

Group Type OTHER

Etafilcon A toric contact lens

Intervention Type DEVICE

contact lens to correct astigmatism

Nelfilcon A toric contact lens

Intervention Type DEVICE

contact lens to correct astigmatism

Etafilcon A toric contact lens/Nelfilcon A toric

Etafilcon A toric contact lens first, then nelfilcon A toric second

Group Type OTHER

Etafilcon A toric contact lens

Intervention Type DEVICE

contact lens to correct astigmatism

Nelfilcon A toric contact lens

Intervention Type DEVICE

contact lens to correct astigmatism

Interventions

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Etafilcon A toric contact lens

contact lens to correct astigmatism

Intervention Type DEVICE

Nelfilcon A toric contact lens

contact lens to correct astigmatism

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The subject must be between 18 and 40 years old.
* The subject must have normal eyes.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
* The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
* The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
* The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
* The subject must be an adapted wearer of soft toric contact lenses in both eyes.
* The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
* Subjects must already possess a wearable pair of spectacles.

Exclusion Criteria

* Ocular or systemic allergies or disease that may interfere with contact lens wear.
* Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation
* Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Diabetes
* Strabismus
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Los Angeles, California, United States

Site Status

Jacksonville, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Marietta, Georgia, United States

Site Status

New York, New York, United States

Site Status

Warwick, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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CR-1476AG

Identifier Type: -

Identifier Source: org_study_id

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