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Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

This study has been completed.
Information provided by (Responsible Party):
Abbott Medical Optics Identifier:
First received: November 8, 2010
Last updated: June 7, 2012
Last verified: June 2012
An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Condition Intervention Phase
Corneal Staining
Device: Biotrue MPS
Device: Investigational MPS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Corneal Staining by Wear Time [ Time Frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 ]
    All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.

Secondary Outcome Measures:
  • Subjective Solution Preference [ Time Frame: Day 4 ]
    Subject asked which solution they prefer based on comfort level.

  • Overall Ocular Comfort [ Time Frame: Day 4 ]
    All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.

Enrollment: 30
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biotrue MPS Device: Biotrue MPS
Multi-purpose contact lens care solution
Experimental: Investigational MPS Device: Investigational MPS
Multi-purpose contact lens care solution


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • were at least 18 years old;
  • were experienced contact lens wearers;
  • were correctable to at least 20/40 or better in both eyes with contact lenses;
  • were in good general health, with healthy eyes (other than requiring vision correction);
  • had not worn lenses for at least 12 hours before each baseline visit;
  • had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
  • had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion Criteria:

  • had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
  • required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
  • had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
  • were currently participating in any other clinical study;
  • had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
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Please refer to this study by its identifier: NCT01240122

United States, California
Abbott Medical Optics Inc
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Abbott Medical Optics
Principal Investigator: Eugenia Y Kao, OD AMO
  More Information

Responsible Party: Abbott Medical Optics Identifier: NCT01240122     History of Changes
Other Study ID Numbers: COBR-109-9608
Study First Received: November 8, 2010
Results First Received: February 15, 2012
Last Updated: June 7, 2012

Keywords provided by Abbott Medical Optics:
Corneal staining and comfort evaluation in normal, habitual contact lens wearers. processed this record on April 25, 2017