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A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192126
First Posted: August 31, 2010
Last Update Posted: January 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
The objective of the study is to evaluate the product performance of visual acuity of the Bausch + Lomb investigational daily disposable contact lenses compared to the currently marketed Johnson & Johnson Acuvue Moist contact lenses.

Condition Intervention
Myopia Contact Lenses Device: Bausch & Lomb new daily disposable Device: Johnson & Johnson Acuvue Moist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: Dispensing Visit and 1 week follow-up ]
    Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.

  • Slit Lamp Examination > Grade 2 [ Time Frame: All study visits from screening through 2 week follow-up ]
    Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2.


Enrollment: 102
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bausch & Lomb new daily disposable
New daily disposable contact lenses
Device: Bausch & Lomb new daily disposable
Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
Active Comparator: Johnson & Johnson Acuvue Moist
Contact lenses
Device: Johnson & Johnson Acuvue Moist
Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be adapted soft contact lens wearers that are interested in daily disposable wear or currently adapted daily disposable soft contact lens wearers.
  • Subjects must agree to wear study lenses on a daily disposable basis for approximately one week and crossover to wear another study lens for one week.
  • Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
  • Subjects must have clear central corneas that are free of any anterior segment disorders.
  • Subjects must be myopic and require lens correction from -1.00 D to -6.00 diopters (D) in each eye.

Exclusion Criteria:

  • Subjects who have worn gas permeable contact lenses within the last 30 days or who have worn polymethylmethacrylate lenses within the last 3 months.
  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an affect 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 who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
  • Subjects who currently wear monovision, multifocal, or toric contact lenses.
  • Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
  • Subjects with anisometropia (spherical equivalent) of greater than 1.00 D.
  • Subjects with any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation).
  • Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Subjects with any "Present" finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation) that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
  • Subjects who are aphakic.
  • Subjects who are amblyopic.
  • Subjects who have presbyopia.
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192126


Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Bev Barna Bausch & Lomb Incorporated
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01192126     History of Changes
Other Study ID Numbers: 662
First Submitted: August 30, 2010
First Posted: August 31, 2010
Results First Submitted: May 28, 2013
Results First Posted: January 3, 2014
Last Update Posted: January 3, 2014
Last Verified: November 2013