Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients

NCT ID: NCT00799422

Last Updated: 2012-11-16

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.

Detailed Description

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Conditions

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Conjunctival Staining

Keywords

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Conjunctival Staining lens parameters lens fit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ReNu MultiPlus

ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Group Type ACTIVE_COMPARATOR

ReNu MultiPlus

Intervention Type DEVICE

Commercially marketed contact lens solution for contact lens care

Contact lenses

Intervention Type DEVICE

Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.

Complete Easy Rub

Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Group Type ACTIVE_COMPARATOR

Complete Easy Rub

Intervention Type DEVICE

Commercially marketed contact lens solution for contact lens care

Contact lenses

Intervention Type DEVICE

Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.

Clear Care

Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Group Type ACTIVE_COMPARATOR

Clear Care

Intervention Type DEVICE

Commercially marketed contact lens solution for contact lens care

Contact lenses

Intervention Type DEVICE

Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.

Interventions

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Complete Easy Rub

Commercially marketed contact lens solution for contact lens care

Intervention Type DEVICE

ReNu MultiPlus

Commercially marketed contact lens solution for contact lens care

Intervention Type DEVICE

Clear Care

Commercially marketed contact lens solution for contact lens care

Intervention Type DEVICE

Contact lenses

Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.

Intervention Type DEVICE

Other Intervention Names

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Complete® Easy Rub® ReNu MultiPlus® Clear Care® ACUVUE® OASYS®

Eligibility Criteria

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Inclusion Criteria

* Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
* Read, sign, and date informed consent/HIPAA document;
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
* Willing and able to discontinue contact lens wear when requested during the study;

Exclusion Criteria

* Evidence or history of ocular disease or pathology;
* One functional eye or a monofit lens;
* Use of concomitant topical ocular prescription or over-the-counter ocular medications;
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Alison Ramsey, O.D.

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M-08-02

Identifier Type: -

Identifier Source: org_study_id