Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses

NCT ID: NCT01100411

Last Updated: 2012-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to evaluate changes in contact lens geometry after lens wear

Detailed Description

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The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear

Conditions

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Myopia

Keywords

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Contact lenses, myopia, lens geometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Air Optix Aqua

Contact lens material: Lotrafilcon A

Group Type ACTIVE_COMPARATOR

Air Optix Aqua

Intervention Type DEVICE

Contact lens material: Lotrafilcon A

Biofinity

Contact lens material: Comfilcon A

Group Type ACTIVE_COMPARATOR

Biofinity

Intervention Type DEVICE

Contact lens material: Comfilcon A

Proclear

Contact lens material: Omafilcon A

Group Type ACTIVE_COMPARATOR

Proclear

Intervention Type DEVICE

Contact lens material: Omafilcon A

Acuvue Oasys

Contact lens material: Senofilcon A

Group Type ACTIVE_COMPARATOR

Acuvue Oasys

Intervention Type DEVICE

Contact lens material: Senofilcon A

Acuvue 2

Contact lens material: Etafilcon A

Group Type ACTIVE_COMPARATOR

Acuvue 2

Intervention Type DEVICE

Contact lens material: Etafilcon A

Purevision

Contact lens material: Balafilcon A

Group Type ACTIVE_COMPARATOR

Purevision

Intervention Type DEVICE

Contact lens material: Balafilcon A

Interventions

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Air Optix Aqua

Contact lens material: Lotrafilcon A

Intervention Type DEVICE

Biofinity

Contact lens material: Comfilcon A

Intervention Type DEVICE

Proclear

Contact lens material: Omafilcon A

Intervention Type DEVICE

Acuvue Oasys

Contact lens material: Senofilcon A

Intervention Type DEVICE

Acuvue 2

Contact lens material: Etafilcon A

Intervention Type DEVICE

Purevision

Contact lens material: Balafilcon A

Intervention Type DEVICE

Other Intervention Names

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Air Optix CV Biofininty Proclear Compatibles Oasys AV 2 PV

Eligibility Criteria

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Inclusion Criteria

* • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;

* Be at least 18 years old;
* Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
* Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
* Has vision correctable to at least 6/12 (20/40) or better at distance in each eye with contact lenses;
* Be experienced at wearing contact lenses.

Exclusion Criteria

* • Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;

* Any systemic disease that adversely affects ocular health
* An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
* Use of any topical ocular medication during trial with the exception of saline drops ;
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance
* Eye surgery within 12 weeks immediately prior to enrolment for this trial;
* Previous corneal refractive surgery;
* Contraindications to contact lens wear;
* Participated or currently enrolled in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
* Be pregnant (formal testing of pregnancy is not required. A participant's verbal report is sufficient);
* Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology lenses 7 calendar days prior.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alcon Call Center

Role: STUDY_CHAIR

Alcon Research

Locations

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Institute for Eye Research

Sydney, New South Wales, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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M-10-01

Identifier Type: -

Identifier Source: org_study_id