Product Feasibility of a New Silicone Hydrogel Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01309100
First received: March 3, 2011
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.


Condition Intervention
Myopia
Device: Investigational Lens
Device: Acuvue Oasys Lens
Device: Air Optix Aqua Lens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Visual Acuity (Investigational vs Air Optix Aqua Lens) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.

  • Visual Acuity (Investigational vs Acuvue Oasys Lens) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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:
  • Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.

  • Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Enrollment: 144
Study Start Date: November 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01309100

Locations
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Tara Vaz, OD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01309100     History of Changes
Other Study ID Numbers: 672E
Study First Received: March 3, 2011
Results First Received: March 27, 2014
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014