A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01449526
First received: October 6, 2011
Last updated: February 13, 2015
Last verified: February 2015
  Purpose

The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.


Condition Intervention
Myopia
Device: B&L Investigational Contact Lens
Device: B&L PureVision Contact Lens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Visual Acuity (VA) [ Time Frame: 4 visits over 3 months ] [ Designated as safety issue: No ]
    Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.


Secondary Outcome Measures:
  • Slit Lamp > Grade 2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.


Enrollment: 166
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B&L Investigational Contact Lens
The Bausch + Lomb investigational silicone hydrogel contact lens
Device: B&L Investigational Contact Lens
Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
Active Comparator: B&L PureVision Contact Lens
The Bausch + Lomb PureVision silicone hydrogel contact lens
Device: B&L PureVision Contact Lens
Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be myopic, and wear contact lenses in each eye.
  • Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion Criteria:

  • Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • 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 who are using any ocular medication.
  • Subjects with any grade 2 or greater finding during the slit lamp examination.
  • Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects who are 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: NCT01449526

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: NCT01449526     History of Changes
Other Study ID Numbers: 661
Study First Received: October 6, 2011
Results First Received: March 28, 2014
Last Updated: February 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
contact lens

ClinicalTrials.gov processed this record on July 05, 2015