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
  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:


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
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

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:
Pharmaceutical Solutions
Contact Lens Solutions
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014