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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01192126
First received: August 30, 2010
Last updated: November 14, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01192126     History of Changes
Other Study ID Numbers: 662
Study First Received: August 30, 2010
Results First Received: May 28, 2013
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014