A Study to Evaluate a New Silicone Hydrogel Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01309893
First received: March 4, 2011
Last updated: November 20, 2014
Last verified: November 2014

March 4, 2011
November 20, 2014
December 2010
January 2011   (final data collection date for primary outcome measure)
Distance High Contrast logMAR Visual Acuity at 1 Week [ Time Frame: Baseline & 1 week ] [ Designated as safety issue: No ]
Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week
Not Provided
Complete list of historical versions of study NCT01309893 on ClinicalTrials.gov Archive Site
  • Slit Lamp Findings ≥ Grade 2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.
  • Overall Comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate 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 lenses.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Myopia
  • Device: Investigational Lens
    Lenses worn on a daily wear basis for one week
  • Device: Air Optix Aqua lens
    Lenses worn on a daily wear basis for one week
  • Experimental: Investigational Lens
    Bausch & Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.
    Interventions:
    • Device: Investigational Lens
    • Device: Air Optix Aqua lens
  • Active Comparator: Air Optix Aqua Lens
    Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.
    Interventions:
    • Device: Investigational Lens
    • 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
66
February 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion Criteria:

  • Any systemic disease affecting ocular health.
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • An active ocular disease, any corneal infiltrative response or are using any ocular medications.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Allergic to any component in the study care products.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01309893
687E
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Robert Steffen, OD, MS Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
November 2014

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