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Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

NCT ID: NCT01423773

Last Updated: 2013-06-28

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study was to compare the fit and comfort of two types of contact lenses.

Detailed Description

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The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.

Conditions

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Ocular Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Lotrafilcon A test/lotrafilcon A control

Lotrafilcon A test contact lens worn first, with lotrafilcon A control contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2.

Group Type OTHER

Lotrafilcon A test contact lens

Intervention Type DEVICE

Silicone hydrogel single vision, soft contact lens with alternate parameters

Lotrafilcon A control contact lens

Intervention Type DEVICE

Silicone hydrogel single vision, soft contact lens

Ultra-High Resolution Optical Coherence Tomographer (OCT)

Intervention Type DEVICE

Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear

Lotrafilcon A control/lotrafilcon A test

Lotrafilcon A control contact lens worn first, with lotrafilcon A test contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2.

Group Type OTHER

Lotrafilcon A test contact lens

Intervention Type DEVICE

Silicone hydrogel single vision, soft contact lens with alternate parameters

Lotrafilcon A control contact lens

Intervention Type DEVICE

Silicone hydrogel single vision, soft contact lens

Ultra-High Resolution Optical Coherence Tomographer (OCT)

Intervention Type DEVICE

Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear

Interventions

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Lotrafilcon A test contact lens

Silicone hydrogel single vision, soft contact lens with alternate parameters

Intervention Type DEVICE

Lotrafilcon A control contact lens

Silicone hydrogel single vision, soft contact lens

Intervention Type DEVICE

Ultra-High Resolution Optical Coherence Tomographer (OCT)

Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear

Intervention Type DEVICE

Other Intervention Names

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Night&Day

Eligibility Criteria

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Inclusion Criteria

* Be of legal age of consent and sign Informed Consent document.
* Normal binocularity.
* Be able to wear soft contact lenses.
* Willing to comply with the wear and study visit schedule.
* Spherical contact lens prescription within 0.50 diopter of the available lens powers.
* Spectacle cylinder less than or equal to 1.50 diopter.

Exclusion Criteria

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bascom Palmer Eye Institute

OTHER

Sponsor Role collaborator

CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianhua Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bascom Palmer Eye Institute

Locations

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McKnight Building, Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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P-367-C-800

Identifier Type: -

Identifier Source: org_study_id