Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

NCT ID: NCT01007812

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.

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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Lotrafilcon B / Comfilcon A

Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week.

Group Type OTHER

Lotrafilcon B contact lens

Intervention Type DEVICE

Silicone hydrogel, toric, soft contact lens

Comfilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel, toric, soft contact lens

Comfilcon A / Lotrafilcon B

Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week.

Group Type OTHER

Lotrafilcon B contact lens

Intervention Type DEVICE

Silicone hydrogel, toric, soft contact lens

Comfilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel, toric, soft contact lens

Interventions

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Lotrafilcon B contact lens

Silicone hydrogel, toric, soft contact lens

Intervention Type DEVICE

Comfilcon A contact lens

Silicone hydrogel, toric, soft contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have a current spectacle prescription, preferably within 6-9 months.
* Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
* Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
* Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.

Exclusion Criteria

* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Currently enrolled in any Clinical Trial.
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Currently wearing soft toric contact lenses as extended wear.
* Currently wearing either of the products to be worn in the study.
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-242-C-032

Identifier Type: -

Identifier Source: org_study_id