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Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

NCT ID: NCT00909792

Last Updated: 2012-06-29

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

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-06-30

Brief Summary

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The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

Detailed Description

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Conditions

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Presbyopia

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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Lotrafilcon B / Senofilcon A

Lotrafilcon B, followed by Senofilcon A

Group Type OTHER

Lotrafilcon B

Intervention Type DEVICE

Silicone hydrogel, soft, multifocal contact lens

Senofilcon A

Intervention Type DEVICE

Silicone hydrogel, soft, multifocal contact lens

Senofilcon A / Lotrafilcon B

Senofilcon A, followed by Lotrafilcon B

Group Type OTHER

Lotrafilcon B

Intervention Type DEVICE

Silicone hydrogel, soft, multifocal contact lens

Senofilcon A

Intervention Type DEVICE

Silicone hydrogel, soft, multifocal contact lens

Interventions

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Lotrafilcon B

Silicone hydrogel, soft, multifocal contact lens

Intervention Type DEVICE

Senofilcon A

Silicone hydrogel, soft, multifocal contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Be at least 35 years of age
* Best-corrected distance visual acuity of at least 20/40 in each eye.
* Spectacle add between +0.75D and +1.50D (inclusive).
* Able to be fit in available study sphere powers (-1.00 to -5.00D)
* Currently wearing soft contact lenses at least 5 days a week.

Exclusion Criteria

* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Astigmatism ≥ 1.00D.
* Currently wearing either of the study products.
Minimum Eligible Age

35 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-319-C-013

Identifier Type: -

Identifier Source: org_study_id