Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

NCT ID: NCT00584831

Last Updated: 2015-05-21

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-02-29

Brief Summary

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The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).

Detailed Description

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Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.

Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 2 LSBO

contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 3 LOSB

contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 4 LBSO

contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 5 LBOS

contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 6 SLOB

contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 7 SLBO

contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 8 SOLB

contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 9 SBLO

contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 10 SBOL

contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 11 OSLB

contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 12 OSBL

contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 13 OBLS

contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 14 OBSL

contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 15 BLSO

contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 16 BLOS

contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 17 BSOL

contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 18 BOLS

contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 19 BOSL

contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Group 1 LSOB

contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

lotrafilcon B

Intervention Type DEVICE

toric contact lens

Interventions

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senofilcon A

toric contact lens

Intervention Type DEVICE

balafilcon A

toric contact lens

Intervention Type DEVICE

omafilcon A

toric contact lens

Intervention Type DEVICE

lotrafilcon B

toric contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. They are aged between 18-39 years.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They can attain at least 6/9 in each eye with their spectacle refraction.
5. They have successfully worn contact lenses within six months of starting the study.
6. They can be fitted with toric soft contact lenses to match the available power range.

Exclusion Criteria

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manchester

OTHER

Sponsor Role collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Morgan, PhD MCOptom

Role: PRINCIPAL_INVESTIGATOR

Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience

Locations

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Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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J07-416

Identifier Type: -

Identifier Source: secondary_id

CR-0725

Identifier Type: -

Identifier Source: org_study_id

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