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

March 3, 2011
March 27, 2014
November 2010
December 2010   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT01309100 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
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Product Feasibility of a New Silicone Hydrogel Contact Lens
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Myopia
  • Device: Investigational Lens
    Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.
  • Device: Acuvue Oasys Lens
    Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.
  • Device: Air Optix Aqua Lens
    Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.
  • Experimental: Investigational Lens
    Bausch & Lomb investigational silicone hydrogel lens.
    Intervention: Device: Investigational Lens
  • Active Comparator: Acuvue Oasys Lens
    Johnson & Johnson Acuvue Oasys contact lens.
    Intervention: Device: Acuvue Oasys Lens
  • Active Comparator: Air Optix Aqua Lens
    Ciba Vision Air Optix Aqua contact lens.
    Intervention: Device: Air Optix Aqua Lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
January 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01309100
672E
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Principal Investigator: Tara Vaz, OD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP