Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

NCT ID: NCT01187355

Last Updated: 2012-07-30

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

591 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.

Detailed Description

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Conditions

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Symptomatic Contact Lens Wearers

Keywords

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Symptomatic, Contact lens care Multi-purpose solution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Alcon MPDS

MPDS used for 30 days as specified in protocol for contact lens care.

Group Type EXPERIMENTAL

FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Intervention Type DEVICE

Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.

Contact lenses

Intervention Type DEVICE

Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.

renu fresh MPS

MPS used for 30 days as indicated for contact lens care.

Group Type ACTIVE_COMPARATOR

renu fresh Multi-Purpose Solution (MPS)

Intervention Type DEVICE

Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.

Contact lenses

Intervention Type DEVICE

Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.

Interventions

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FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.

Intervention Type DEVICE

renu fresh Multi-Purpose Solution (MPS)

Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.

Intervention Type DEVICE

Contact lenses

Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.

Intervention Type DEVICE

Other Intervention Names

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renu® fresh™ Multi-Purpose Solution

Eligibility Criteria

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Inclusion Criteria

* Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
* Vision correctable to 20/30 or better with contact lenses.

Exclusion Criteria

* Sensitivity to multi-purpose solutions.
* Use of any topical ocular OTC or prescribed topical ocular medications.
* History (6 months) or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Medical condition or use of medications that cause ocular side effects.
* Participation in any investigational study within the past 30 days.
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

Locations

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Contact 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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C-09-074

Identifier Type: -

Identifier Source: org_study_id