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Product Performance of a Toric Contact Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658996
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : February 16, 2011
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Brief Summary:
Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens

Condition or disease Intervention/treatment Phase
Myopia Astigmatism Device: SofLens DD Toric Device: Ciba Vision Focus Dailies Toric Contact Lens Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.
Study Start Date : April 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SofLens DD Toric
Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
 Device: SofLens DD Toric
daily disposable wear contact lens for 2 weeks
Active Comparator: Ciba Vision Toric Lens
Ciba Vision Focus Dailies Toric Contact Lens
 Device: Ciba Vision Focus Dailies Toric Contact Lens
daily disposable wear contact lens for 2 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms and Complaints [ Time Frame: Over-all follow-up visits for 2 week period ]
    1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.

  2. Contact Lens High Contrast Visual Acuity [ Time Frame: Over-all follow-up visits, 2 weeks ]
    VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.


Secondary Outcome Measures :
  1. Slit Lamp Findings [ Time Frame: Over-all follow-up visits, 2 weeks ]
    Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
  • Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
  • Clear central cornea

Exclusion Criteria:

  • Systemic disease affecting ocular health
  • Using systemic or topical medications
  • Wears monovision or multifocal contact lenses
  • Any grade 2 or greater slit lamp findings
  • Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
Contacts and Locations
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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): NCT00658996


Locations
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Malaysia
Laser Focus Sdn Bhd, Vision Correction Centre
Johor Bahru, Malaysia, 80400
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Gerard Cairns, PhD,MCOptom Bausch & Lomb Incorporated
Principal Investigator: Benny Chian, MCOptom,DO Laser Focus Sdn Bhd, Vision Correction Centre
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00658996    
Other Study ID Numbers: 559
First Posted: April 16, 2008    Key Record Dates
Results First Posted: February 16, 2011
Last Update Posted: December 12, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases