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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
  Purpose

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


Condition Intervention
Myopia
Device: Investigational 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:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 66
Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Lens
Bausch & Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.
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
Active Comparator: Air Optix Aqua Lens
Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01309893

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Robert Steffen, OD, MS Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01309893     History of Changes
Other Study ID Numbers: 687E
Study First Received: March 4, 2011
Results First Received: November 4, 2014
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Contact lens

ClinicalTrials.gov processed this record on November 27, 2014