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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00636194

First received: March 7, 2008

Last updated: December 7, 2011

Last verified: December 2011

History of Changes

Purpose

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

Condition	Intervention
Adverse Effect of Contact Lens Solution	Device: Bausch & Lomb Multipurpose Solution Device: Alcon OptiFree Replenish Multipurpose Solution


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Official Title:	Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

Drug Information available for: Dipivefrin hydrochloride

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:

Subjective Assessment of Comfort and Cleanliness [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.

Secondary Outcome Measures:

Symptoms and Complaints [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.
Graded Slit Lamp Findings > Grade 2 [ Time Frame: 2 week follow-up visit ] [ Designated as safety issue: No ]
Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.


Enrollment:	361
Study Start Date:	February 2008
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: B&L Multipurpose solution Bausch & Lomb Multipurpose Contact Lens Solution	Device: Bausch & Lomb Multipurpose Solution daily care of contact lenses
Active Comparator: Alcon Multipurpose Solution Alcon OptiFree Replenish Multipurpose Contact Lens Solution	Device: Alcon OptiFree Replenish Multipurpose Solution daily care for contact lenses

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636194

Locations


Malaysia
Laser Focus Sdn Bhd, Vision Correction Centre
Jalan Kuning, Tamn Pelangi, Johor Bahru, Malaysia, 80400

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators


Study Director:	Mohinder Merchea, OD, PhD	Bausch & Lomb Incorporated

More Information


Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT00636194 History of Changes
Other Study ID Numbers:	562
Study First Received:	March 7, 2008
Results First Received:	December 14, 2010
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Pharmaceutical Solutions Dipivefrin Contact Lens Solutions Adrenergic Agonists Adrenergic Agents	Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Disinfectants Anti-Infective Agents

ClinicalTrials.gov processed this record on September 29, 2016

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