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

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ClinicalTrials.gov Identifier: NCT00636194
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : February 15, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution

Condition or disease Intervention/treatment Phase
Adverse Effect of Contact Lens Solution Device: Bausch & Lomb Multipurpose Solution Device: Alcon OptiFree Replenish Multipurpose Solution Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Subjective Assessment of Comfort and Cleanliness [ Time Frame: 7 days ]
    Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.


Secondary Outcome Measures :
  1. Symptoms and Complaints [ Time Frame: 2 weeks ]
    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.

  2. Graded Slit Lamp Findings > Grade 2 [ Time Frame: 2 week follow-up visit ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00636194     History of Changes
Other Study ID Numbers: 562
First Posted: March 14, 2008    Key Record Dates
Results First Posted: February 15, 2011
Last Update Posted: December 13, 2011
Last Verified: December 2011

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