Safety and Efficacy of a Contact Lens for Daily Disposable Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01365039
First received: June 1, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.


Condition Intervention
Myopia
Device: Test, daily disposable contact lens
Device: SofLens daily disposable contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Slit Lamp Findings > Grade 2 [ Time Frame: 4 visits over 3 months ] [ Designated as safety issue: No ]
    Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses

  • High Contrast, Distance logMAR 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. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint


Enrollment: 173
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test lens
Test contact lens will be worn on a daily disposable wear basis.
Device: Test, daily disposable contact lens
Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Active Comparator: SofLens lens
The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
Device: SofLens daily disposable contact lens
Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.

  Eligibility

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

Inclusion Criteria:

  • Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
  • Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
  • Subjects must be free of any anterior segment disorders.
  • Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

Exclusion Criteria:

  • 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 any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects who have had any corneal surgery (eg, refractive surgery).
  • Subjects who are allergic to any component in the study care products.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365039

Locations
United States, New York
Bausch & Lomb, Inc.
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Beverly Barna, CCRA Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01365039     History of Changes
Other Study ID Numbers: 690
Study First Received: June 1, 2011
Results First Received: November 20, 2013
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bausch & Lomb Incorporated:
contact lens

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014