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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
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
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
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

No publications provided

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:
Dipivefrin
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013