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Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution

NCT ID: NCT00636194

Last Updated: 2011-12-13

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

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-04-30

Brief Summary

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To evaluate the product performance of a Bausch \& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution

Detailed Description

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Conditions

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Adverse Effect of Contact Lens 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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B&L Multipurpose solution

Bausch \& Lomb Multipurpose Contact Lens Solution

Group Type EXPERIMENTAL

Bausch & Lomb Multipurpose Solution

Intervention Type DEVICE

daily care of contact lenses

Alcon Multipurpose Solution

Alcon OptiFree Replenish Multipurpose Contact Lens Solution

Group Type ACTIVE_COMPARATOR

Alcon OptiFree Replenish Multipurpose Solution

Intervention Type DEVICE

daily care for contact lenses

Interventions

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Bausch & Lomb Multipurpose Solution

daily care of contact lenses

Intervention Type DEVICE

Alcon OptiFree Replenish Multipurpose Solution

daily care for contact lenses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects are adapted wearers of silicone hydrogel contact lenses
* VA correctable to 0.3 LogMAR or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria

* Systemic disease affecting ocular health
* Using systemic or topical medications
* wear a monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohinder Merchea, OD, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Laser Focus Sdn Bhd, Vision Correction Centre

Jalan Kuning, Tamn Pelangi, Johor Bahru, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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562

Identifier Type: -

Identifier Source: org_study_id