Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Product Feasibility of a New Silicone Hydrogel 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: NCT01309100
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

Condition or disease Intervention/treatment Phase
Myopia Device: Investigational Lens Device: Acuvue Oasys Lens Device: Air Optix Aqua Lens Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study Start Date : November 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Investigational Lens
Bausch & Lomb investigational silicone hydrogel lens.
 Device: Investigational Lens
Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.
Active Comparator: Acuvue Oasys Lens
Johnson & Johnson Acuvue Oasys contact lens.
 Device: Acuvue Oasys Lens
Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.
Active Comparator: Air Optix Aqua Lens
Ciba Vision Air Optix Aqua contact lens.
 Device: Air Optix Aqua Lens
Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Visual Acuity (Investigational vs Air Optix Aqua Lens) [ Time Frame: 1 week ]
    The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.

  2. Visual Acuity (Investigational vs Acuvue Oasys Lens) [ Time Frame: 1 week ]
    The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.


Secondary Outcome Measures :
  1. Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) [ Time Frame: 1 week ]
    The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.

  2. Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) [ Time Frame: 1 week ]
    The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
  • Subjects must be myopic and require lens correction

Exclusion Criteria:

  • Subjects with any systemic disease affecting ocular health.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects with an active ocular disease or are using any ocular medication.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Contacts and Locations
Go to 
Top of Page 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): NCT01309100


Locations
Layout table for location information
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Layout table for investigator information
Principal Investigator: Tara Vaz, OD Bausch & Lomb Incorporated
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01309100    
Other Study ID Numbers: 672E
First Posted: March 4, 2011    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases