Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

NCT ID: NCT00762502

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-01-31

Brief Summary

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To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.

Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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senofilcon A toric bilaterally

senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

Group Type ACTIVE_COMPARATOR

senofilcon A toric contact lens

Intervention Type DEVICE

soft contact lens

balafilcon A toric bilaterally

balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.

Group Type ACTIVE_COMPARATOR

balafilcon A toric contact lens

Intervention Type DEVICE

soft contact lens

senofilcon A/balafilcon A contralaterally

senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.

Group Type ACTIVE_COMPARATOR

senofilcon A toric contact lens

Intervention Type DEVICE

soft contact lens

balafilcon A toric contact lens

Intervention Type DEVICE

soft contact lens

Interventions

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senofilcon A toric contact lens

soft contact lens

Intervention Type DEVICE

balafilcon A toric contact lens

soft contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Able to wear study lenses in parameters available
* Non-presbyopes between the ages of 18-45
* Understand and sign informed consent
* Willing to follow the protocol
* Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
* Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
* Adapted soft contact lens wearer
* Swims no more than once a week
* Has a wearable pair of spectacles.

Exclusion Criteria

* Any ocular or systemic disorder which may contraindicate contact lens wear
* Any topical ocular medication
* Aphakic
* Corneal refractive surgery
* Corneal distortion from hard CL wear or keratoconus
* Pregnant or lactating
* Grade 2 or worse slit lamp signs
* Infectious disease
* Previous clinical study within 2 weeks
* Don't agree to participate
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
* Previous adverse effects that contraindicate extended lens wear.
* Self-reported symptoms of itchiness or scratchiness with habitual lenses.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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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Boston, Massachusetts, United States

Site Status

Newtown, New South Wales, Australia

Site Status

Camberwell, Victoria, Australia

Site Status

Hawthorn, Victoria, Australia

Site Status

Keilor, Victoria, Australia

Site Status

Melbourne, Victoria, Australia

Site Status

Mitcham, Victoria, Australia

Site Status

Yallourn, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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CR-4498

Identifier Type: -

Identifier Source: org_study_id

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